Elafibranor phase 3 results

elafibranor phase 3 results About Primary Biliary Cholangitis (PBC) PBC is a serious chronic, progressive hepatic disease that leads to inflammation and scarring of the small bile ducts in the liver which, if left untreated, can lead to cirrhosis, liver failure and ultimately liver transplantation. Oct 01, 2020 · Prigent said that Genfit is proceeding with plans for a Phase 3 test of its drug in the rare disorder. The number of neoplastic nodules that developed in mice exposed for several months to a NASH-inducing diet was significantly attenuated in mice that received elafibranor. Apr 20, 2018 · This review will discuss four medications that are in phase III randomized controlled trials (RCTs): elafibranor, obeticholic acid (OCA), cenicriviroc (CVC), and selonsertib (SEL). ABOUT PBC "PBC" is a chronic disease in which bile ducts in the liver Jun 05, 2019 · Genfit initiated a phase 2 trial to evaluate the effect of elafibranor on hepatic lipid composition in patients with nonalcoholic fatty liver disease, according to a press release. Elafibranor is currently being evaluated in a clinical phase 3 study for the treatment of NASH. Evaluation of this molecule for the treatment of PBC in a clinical phase 2 study is also planned. GENFIT: First Half-Year 2020 Financial Report and New Corporate Strategy Market Watch · 2 days ago. patients who should be treated: genfit announces trial of elafibranor did not show significant effect on nash patients. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Allergan and Madrigal are also testing drug candidates at phase III, but are currently behind Genfit, which is expecting phase III results at the end of the year. OCA has co-primary endpoints in its Phase 3 trial : 1) NASH resolution without worsening of fibrosis and 2) Decrease in NAS scores of at least 2 points without worsening of fibrosis, while elafibranor only has the first endpoint. 3. Stable dose of vitamin E,  14 May 2020 GENFIT announced that the phase 3 RESOLVE-IT trial of elafibranor in of all- cause mortality, cirrhosis, and liver-related clinical outcomes for  Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Despite the problems experienced by other late-stage contenders in this space and indeed the debated success of Genfit’s own phase II study of elafibranor in NASH in 2015, Hum seems Nov 09, 2020 · The Phase 3 trial conducted by the companies included 43,358 participants, and Pfizer reports “no serious safety concerns have been observed” thus far in addition to the positive prevention rate. Share your opinion and gain insight from other stock traders and investors. , is a participant in a Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna. Jan 31, 2019 · Elafibranor is a new generation dual PPAR (PPAR-α, δ) agonist and a metabolic modulator in Phase 3 clinical trial for NASH fibrosis and Phase 2 pediatric NASH. The primary endpoint is the resolution of NASH without worsening of fibrosis after 72 weeks of treatment. AstraZeneca announced Wednesday that it still expects results from phase three of its COVID-19 vaccine trial to be ready by the end of 2020. Elafibranor and cenicriviroc, which Allergan acquired with Tobira for $534m, are the other two phase III Nash assets, and are somewhat further behind Ocaliva and selonsertib. Oct 02, 2018 · GENFIT: New data to be presented at 2018 AASLD meeting, ahead of key results expected in 2018 and 2019 KOL event to be held ahead of expected data release with elafibranor in PBC by end of 2018 (Phase 2) and in NASH end of 2019 (Phase 3) Apr 15, 2019 · In the phase II study, two different doses of elafibranor significantly decreased mean ALP compared with placebo (P<0. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a severe liver disease. The reduction of VLCFAs is thought to be a promising therapeutic target, thus the results initiation of a human proof-of-concept study of VK0214. Clinical Trial Results: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid In the phase 3 trial, the AURORA study recruited nearly 2000 patients to obtain similarly positive results [261]. RESOLVE-IT is a  12 May 2020 ANALYSIS OF RESOLVE-IT PHASE 3 TRIAL OF ELAFIBRANOR DID NOT THE EFFECT OF ELAFIBRANOR ON CLINICAL OUTCOMES. Sep 24, 2020 · Elafibranor, currently in a phase 3 clinical trial for PBC (ELATIVE), has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted Breakthrough Therapy designation by the FDA and Orphan Drug designation by the FDA and EMA in this condition. Nov 10, 2020 · Pfizer released the interim Phase 3 results for its mRNA coronavirus vaccine developed together with German company BioNTech, revealing incredible news about the drug’s efficacy. And then there is Gilead, which has a failed Phase III trial of selonsertib, a drug it developed in-house. Actions au Port. 1. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Oct 01, 2020 · Phase 3: NCT03280056: Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients: GNFT: Genfit SA: 2020-10-01: Phase 3: NCT02704403: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) GRTX: Galera Therapeutics, Inc. Participants will continue the elafibranor dose received during the double blind period. 2016 May;150(5):1147-1159. The vaccine has Elafibranor, currently in a phase 3 clinical trial for PBC (ELATIVE), has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted Breakthrough Therapy Dec 29, 2018 · Elafibranor is one of a small band of drugs barreling toward phase 3 NASH readouts. 4 Additionally, there are 7 NASH pipeline products with active phase 2 programs that have earned Fast Track designation from the FDA for genfit announces trial of elafibranor did not show significant effect on nash patients. M) Day 0-2. resmetrion 80-100 mg daily § Interim subpart H endpoint: NASH resolution Using a pretreatment dataset of the Phase 3 RESOLVE-IT study, after the screening of the first 500 patients, new results confirm the diagnostic potential of circulating microRNAs and the relevance of GENFIT’s signature to identify patients with active NASH (NAS≥4) and significant fibrosis (F≥2), i. In addition, Elafibranor has recently been granted “Breakthrough Therapy The basis for advancing to Phase 3 is the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in the Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients. May 11, 2020 · INTERMEDIATE RESULTS. Phase 3 trials include large numbers of people to make sure that the result is valid. ‘These results suggest the treatment has substantial anticholestatic efficacy that we hope will translate into long-term benefits for patients. Phase 2b Jul 30, 2019 · Allergan and Madrigal are also testing drug candidates at phase III, but are currently behind Genfit, which is expecting phase III results at the end of the year. May 11, 2020 Phase 3 Topline Data. 3 µ M 4. Patients were randomized 2:1 to receive elafibranor 120mg or placebo once May 01, 2016 · Results of the secondary histologic outcomes (Supplementary Table 3) show no significant difference between elafibranor and placebo. May 14, 2019 · RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Four compounds are in Phase 3 to date, but Tobira (Allergan) delayed their results to september 2020, to date only 3 compounds are still in course for 2019: OCALIVA (Intercept) ELAFIBRANOR (Genfit) Nov 16, 2020 · This envelope was determined to allow the continued operation of the Company’s business until the ELATIVE™ Phase 3 clinical trial evaluating elafibranor in PBC can be monetized. Feb 21, 2020 · Genfit’s shares were in the red Friday morning after the French biotech announced it was delaying a data readout for its potential blockbuster fatty liver hopeful elafibranor. The GOLDEN study6 was a phase 2b multi-centre (Europe and USA), double-blind, randomized controlled trial comparing elafibranor Genfit did the same earlier this year after elafibranor, another PPAR agonist, crashed out in phase III (Genfit’s predictable liver disease failure sets up a cirrhosis pivot, May 12, 2020). 5mg group did not meet any of the 3 efficacy endpoints. A significantly higher rate of cardio-pulmonary and  8 Jul 2020 Federico Grossi, MD, chief medical officer at Apellis Pharmaceuticals, discusses the results of the PEGASUS study, a phase 3 clinical trial  19 Sep 2020 Benjamin Solomon, MBBS, PhD, FRACP, discusses interim findings from the phase 3 CROWN study in ALK-positive non–small cell lung . * Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis * GENFIT will engage with regulatory authorities to determine next steps regarding the extension phase evaluating the effect of elafibranor on clinical outcomes May 11, 2020 · In the meantime, the company says it will continue as planned with a Phase 3 trial evaluating elafibranor as a treatment in patients with primary biliary cholangitis and development of NIS4, a “We are not terribly surprised elafibranor failed in the RESOLVE-IT Phase 3 study in NASH as we were pretty skeptical ahead of results based on our diligence into elafibranor’s Phase 2 data The detailed results of the GOLDEN-505 trial represent an essential contribution to the global effort to address this disease related to the obesity and diabetes epidemics (and for this reason considered a priority by the regulatory agencies, as confirmed by the fast-track designation granted to Elafibranor, as well as by the Subpart H process Aug 26, 2020 · Elafibranor 80mg for double blind period (52 to 104 weeks). 52-Week High $3. Following the positive Phase 2 data of elafibranor in PBC, the U. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC at the beginning of next year following its positive Phase 2 results. Because the expression and activation of CCR2 and CCR5 receptors on macrophages elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe GENFIT: First Half-Year 2020 Financial Report and New Corporate Strategy Market Watch · 3 days ago. Phase 3. The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or Future phase 3 trials will evaluate the effect of elafibranor on the rate of progression to cirrhosis as a result of the resolution of NASH or also through a direct anti-fibrotic effect. NCT02704403: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT) Time Line. Jun 24, 2019 · Results from a Phase 3 study in patients with NASH is expected in the fourth quarter 2019. The drug, elafibranor, did not beat May 11, 2020 · Based on an interim analysis, a Phase 3 clinical trial, RESOLVE-IT, evaluating Genfit's (NASDAQ:GNFT) elafibranor in adults with nonalcoholic steatohepatitis (NASH) failed to achieve the primary May 11, 2020 · Though elafibranor missed the primary goal of a mid-stage trial back in 2015, GenFit said the results were affected by unexpected circumstances and decided to forge ahead into a late-stage program. “That was the primary endpoint for the global phase 3 trial that is still ongoing. Genfit’s disappointing phase III trial — which failed to meet both its primary endpoint of NASH resolution Apr 14, 2019 · Elafibranor was globally well tolerated and did not exacerbate or induce pruritus. Elafibranor has experienced mixed results in its Phase IIb GOLDEN trial due to the inclusion of non-alcoholic steatohepatitis (NASH) patients with Non-Alcoholic Fatty Liver Disease Activity Score (NAS) of 3 or above Elafibranor is a dual peroxisome proliferator-activated receptor (PPAR) alpha/delta agonist that modulates lipid synthesis with potential anti–inflammatory and anti-fibrotic effects within the liver. 2018 Half-Year Results: Cash Position at End of Period at €238M and Significant Advances in the Clinical Development of Elafibranor - Completion of enrollment of approx. Phase 2b data presented at EASL 2018. 12 May 2020 Of the 717 patients in the trial who received elafibranor, the response “These results are highly disappointing, not only for the Genfit team, but  23 Jul 2020 In May, GENFIT disclosed interim data from the Phase III study and the Elafibranor showed promising results in a Phase II clinical trial for  22 Jul 2020 Genfit SA discontinued the late-stage clinical trial of elafibranor to treat patients with a liver condition following interim results, announced in  Elafibranor. PBC is a rare disease so the market potential is much smaller than Nash, and with several companies now focused on this space, the competition is hotting up. 04-08-2020 Full-Year 2019 Financial Results and Corporate Update Jun 27, 2018 · The effect of elafibranor on liver tumor development was investigated in proof of concept studies in different NASH disease models. Resmetirom. 1000-patient study cohort for Phase 3 RESOLVE-IT study, on the basis of which conditional marketing approval for elafibranor in NASH could be obtained in 2020. N. Despite the problems experienced by other late-stage contenders in this space and indeed the debated success of Genfit’s own phase II study of elafibranor in NASH in 2015, Hum seems NEW YORK (GenomeWeb) – As part of an upcoming phase III study of its investigational non-alcoholic steatohepatitis (NASH) drug elafibranor, French biopharmaceutical firm Genfit is aiming to validate a diagnostic method that uses blood-based biomarkers to identify patients with the disease who are candidates for treatment. About elafibranor Following the May 11, 2020 announcement of the interim results from the RESOLVE-IT Phase 3 clinical trial evaluating elafibranor in adults with NASH and fibrosis, GENFIT outlines the main operational and financial implications of this announcement: Operational implications Feb 21, 2020 · Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. GENFIT Announces Results of NIS4, an Jun 05, 2017 · Key NASH Therapies: Resolution of NASH Results from separate studies, not head to head – Time points and populations may differ between studies Bariatric Surgery[6] Pts(%) 11/ 145 8/ 144 36 21 22 13 85 6 47 21 39 9 29 5 8 Vitamin E 800 IU/day[1] Pioglitazone 30 mg/day[1] Liraglutide 1. The biotech company says that Dec 05, 2019 · What the clinical trials found: Genfit’s Phase II trial of elafibranor saw the candidate meet its primary and secondary endpoints, demonstrated by the resolution of NASH, improvements in cardiovascular risk factors and a reduction of liver fibrosis. INTERIM RESULTS The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4, fibrosis stage 2 or 3. Among the different types of drugs Elafibranor is predicted to hold maximum share in the market and also exhibit maximum growth rate. WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR? 2023. Phase III. Food and Drug Administration (FDA) granted elafibranor Breakthrough Therapy designation. The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4, fibrosis stage 2 or 3. Apr 13, 2019 · “Strong alkaline phosphatase and composite results further justify moving elafibranor into a phase 3 trial in PBC patients with inadequate response to UDCA. Serious News for May 12, 2020 · Genfit’s lead drug failed a phase 3 study in NASH, joining a growing number of fatty liver prospects that have bitten the dust. “These results are  12 mai 2020 Elafibranor n'a pas démontré d'effet statistiquement significatif sur le critère principal sur l'occurrence d'évènements cliniques tangibles (« clinical outcomes ») Néanmoins , concernant l'essai de phase III d'Elafibranor , sa  Resmetirom is now being assessed in the large, phase 3 MAESTRO-NASH clinical trial Oral GLP-1 therapies are currently being tested with promising results for Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α  4 May 2020 effective products, to achieve positive results in clinical trials, to obtain Ocaliva. Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening. Feb 21, 2020 · Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. e. Results from a Phase 3 study in patients with NASH is expected in the fourth quarter 2019. Genfit’s disappointing phase III trial — which failed to meet both its primary endpoint of NASH resolution The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. It is a Phase 3 Data. Jun 01, 2017 · Free Online Library: Genfit gets positive recommendation for continuation of Phase 3 Elafibranor clinical trial. The study was designed to compare the GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH . The vaccine has Sep 17, 2020 · Tony Potts, a 69-year-old retiree living in Ormond Beach, Fla. Elafibranor evidenced positive results in the targeting of PBC—both primary and secondary endpoints met Feb 20, 2020 · Topline interim results will be announced in the weeks following receipt of FDA insight. This is the first randomized study to investigate interferon-free treatment response in this patient population. 0. There are also less common very early (phase 0) and later (phase 4) phases. Future phase 3 trials will evaluate the effect of elafibranor on the rate of progression to cirrhosis as a result of the resolution of NASH or also through a direct anti- fibrotic effect. Oct 01, 2020 · After negative interim data from its Phase III RESOLVE-IT trial of elafibranor in non-alcoholic steatohepatitis (NASH) and fibrosis back in May, France’s GENFIT discontinued the trial in July. The Phase 3 clinical trial evaluated the effects of elafibranor in comparison with a placebo in 1070 patients (ITT population) with a NASH determined by biopsy and defined as a NAS greater than or equal to 4 and a fibrosis stage of 2 or 3 Patients were randomized to 2: 1, receiving either elafibranor 120mg or placebo daily Elafibranor, currently in a phase 3 clinical trial for PBC (ELATIVE), has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted Breakthrough Therapy INTERIM RESULTS . Phase 2b (GOLDEN) results were published online in Gastroenterology in February 2016 and will be fully available in the paper version in May 2016. About RESOLVE-IT. 4 Jun 2018 Much as he did for trials involving OCA, Dr. Apr 17, 2019 · Elafibranor is a peroxisome proliferator-activated receptor agonist. Genfit’s 2,000-patient Phase III RESOLVE-IT trial investigating elafibranor in nonalcoholic steatohepatitis (NASH) is likely to close enrolment sometime in September, with the female patient target already reached. The drug was granted ‘Fast Track’ designation by the FDA in February 2014 for the treatment of NASH and received clearance by the FDA in Results from a Phase 3 study in patients with NASH is expected in the fourth quarter 2019. MGL-3196 Elafibranor Elafibranor Selonsertib Obeticholic acid Cenicriviroc Friedman, Nat Med, 2018 Obeticholic acid Positive results from REGENERATE: A phase 3 international, randomized, placebo-controlled study of obeticholic acid (FXR agonist) treatment for NASH These results suggest that SIRT1 mediated the renal protective effects of chronic elafibranor treatment in HFD mice by activation of PPARα and PPARδ (Figures 4(a), 6(c), and 6(d)). It improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. (NYSE: PFE) announced today positive top-line results from the Phase 3 JADE REGIMEN study. by "M2 EquityBites (EQB)"; Business Clinical trials Gastrointestinal system Liver Jan 29, 2020 · Elafibranor, under clinical investigation by Genfit in the RESOLVE-IT Phase 3 trial, is promising based on the mechanism of action (PPAR α/δ agonist) and Phase 2 data, which showed improvement in lipid profiles, insulin sensitivity and glucose metabolism, and anti-inflammatory properties. and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its Apr 18, 2019 · Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. LAST PATIENT'S LAST BIOPSY – 4Q19. May 11, 2020 · INTERIM RESULTS . Elafibranor was granted a Breakthrough Therapy Designation in this In a Phase 2 clinical trial, elafibranor showed impressive results on PBC with a significant reduction in alkaline phosphatase, as well as on the composite endpoint used for Phase 3, and on other markers of the disease. 0 2 4 6 8 10. Presenting their findings at the 53rd International Liver Congress in Vienna, researchers in the Phase II study enrolled 45 people with PBC who did not have cirrhosis and did not respond adequately to treatment with ursodeoxycholic acid (UDCA). 2019 was a pivotal year in NASH treatment, to date, two Phase 3 trials published their intermediate results and one Phase 3 will be published Q1 2020. Future phase 3 trials will evaluate the effect of elafibranor on the rate of progression to cirrhosis as a result of the resolution of NASH or also through a direct anti-fibrotic effect. 24, 2019 Terns Pharmaceuticals, Inc. Sep 01, 2020 · Elafibranor (GFT505) is an agonist of the peroxisome proliferator-activated receptor-α(PPAR-alpha) and peroxisome proliferator-activated receptor-δ(PPAR-δ). LDH release (fold change over vehicle control) 1. Elafibranor concentration (µM) Elafibranor treatment results in decreased inflammatory phenotype. 30. The phase 3 RESOLVE-IT trial was evaluating the drug in adults with NASH and fibrosis, but was unable to meet the primary endpoint of disease resolution without Elafibranor has shown small reversible creatinine elevations in the safety results of phase 2 trials. We considered the FDA's feedback regarding the other completed Phase 3 NASH Considering the evolving NASH landscape and the results of the analysis from development of elafibranor in NASH, and officially terminated RESOLVE-IT,  GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis May 11, 2020 Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a rare liver disease. GENFIT’s phase 3 registration trial RESOLVE-IT is an international study evaluating the efficacy and safety of elafibranor 120mg once daily in patients with NASH and fibrosis. Jul 22, 2020 · Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and GENFIT’s clinical team is now fully focused on the initiation of the Phase 3 clinical trial. The phase 2b trial that was launched in 2012 was the biggest interventional trial and the first real international study to be done on NASH. Pre-clinical studies Elafibranor is an agonist of the peroxisome proliferator−activated receptor-α and peroxisome proliferator−activated receptor-δ. Ongoing Phase 3 trials of the cutting edge mRNA Oct 26, 2017 · Results statistically significant reduction in levels of very long chain fatty acids (VLCFAs) in plasma and key tissues, including the liver, brain, and spinal cord. The study pitted elafibranor against placebo in 1,070… Nov 09, 2020 · The first set of results from our phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer CEO Albert Bourla said in a statement. There are about 200 male patients yet to be enrolled, sources revealed on the sidelines of the recent Paris NASH Meeting. 2021. PRESS RELEASES. 7. The results on efficacy and safety of the dedicated RESOLVE-IT phase 3 trial and the phase 3 trials on combinations with other developmental drugs, will decide if elafibranor has role in the future treatment of NAFLD/NASH. 0M. About NASH A phase 3 trial on elafibranor in 2,000 NASH patients (NAS ≥4) with stage 2/3 fibrosis is ongoing (RESOLVE-IT, NCT0270-4403) . 0 1 2 . Jun 01, 2019 · From these results it could be also speculated that elafibranor inhibits the de novo fatty acid synthesis of the cell itself. GENFIT has published the first results of its Elafibranor efficacy and safety clinical trial for   22 Jul 2020 The company said elafibranor has demonstrated promising results in a Phase II clinical trial for PBC, adding its team is now working on  10 Mar 2016 NAS score ≥4. It is important to note that the histological endpoints for each phase III study are slightly different, which preclude head‐to‐head comparison of the results. The primary outcome is the proportion of patients with resolution of NASH without worsening of fibrosis at 72 weeks. In the face of a 65% drop in its Nasdaq stock price on Monday, Genfit plans to continue testing elafibranor in a different indication — the autoimmune liver disease primary biliary cholangitis — where it hopes for better results. Nov 10, 2019 · The phase 3 data in roughly 1,000 patients will show the effects after 72 weeks of treatment with either elafibranor or placebo. About Resolve-It RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Enrollment has begun; preliminary results are expected in early 2023. Food and Drug Administration for this indication. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a Nov 10, 2020 · Pfizer released the interim Phase 3 results for its mRNA coronavirus vaccine developed together with German company BioNTech, revealing incredible news about the drug’s efficacy. Apr 29, 2019 · Results from this trial are not expected until July 2020. It is followed by Obeticholic Acid (OCA) in the market. RECALL. Elafibranor was granted a Breakthrough Therapy Designation for this indication. The drug, elafibranor, did not beat placebo at improving NASH symptoms without making liver scarring worse, interim data show. GENFIT has completed patient enrolment in a Phase lla trial to investigate the efficacy and safety of elafibranor for the treatment of patients with Primary Biliary Cholangitis (PBC) and inadequate response to ursodeoxycholic acid. analysis-2030262 1920. Jul 22, 2020 · Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and GENFIT's clinical team is now fully focused on the initiation of the Phase 3 clinical trial. Mar 16, 2019 · In the Phase 2 trial that evidenced some challenges, “Genfit saw promise for elafibranor in treating patients with more severe fibrosis and modified its design for its phase 3 study” according to the Motley Fool ’s Speights. Related Links. Genfit’s disappointing phase III trial — which failed to meet both its primary endpoint of NASH resolution Sep 25, 2020 · GENFIT has started the phase 3 ELATIVE clinical trial for evaluating the efficacy and safety of elafibranor for the treatment of primary biliary cholangitis (PBC). 0 12. ” The FDA’s designation is based on results from a 12-week, double-blind, randomised placebo-controlled Phase II trial that treated non-cirrhotic subjects with PBC that showed an inadequate response to UDCA. 93 Find the latest Genfit S. It is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. That upcoming data drop remains the key moment in the near-term future of the peroxisome proliferator-activated receptor agonist. GENFIT’s clinical team is focused on the launch of a Phase III study. The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or May 11, 2020 · The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4 May 14, 2020 · The multicenter, double-blind, placebo-controlled phase 3 trial evaluated the efficacy and safety of elafibranor in 1070 adult patients with biopsy proven NASH as defined by NAS score greater than May 11, 2020 · Genfit’s lead drug failed a phase 3 study in nonalcoholic steatohepatitis (NASH), joining a growing number of fatty liver prospects that have bitten the dust. This marks the second delay of data since September and INTERIM RESULTS. On The Radar Elafibranor is an agonist of the peroxisome proliferator−activated receptor-α and peroxisome proliferator−activated receptor-δ. Nov 26, 2019 · Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support A number of phase 3 clinical trials are currently ongoing including Elafibranor, a dual PPAR α/δ agonist, Cenicriviroc, a CCR2/CCR5 chemokine antagonist, the nuclear bile acid receptor FXR agonist obeticholic acid, Aramchol, a fatty acid bile acid conjugate that modulates SCD-1, and Resmetrion, a liver-specific THR-β agonist. • Phase III RESOLVE-IT results in Q4 2019 • Launch of combination therapy clinical program: diagnostic, licensed Chinese rights to elafibranor to Upon commercial launch of elafibranor for the treatment of NASH in Greater China, GENFIT will be entitled to receive mid-teen percentage royalties from Terns based on sales in the territory. S. Interim Phase III data for elafibranor is expected soon and, depending on results and filing timeline, may receive FDA approval in 2021. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system. The published BOSTON study results are based on the multi-center, Phase 3, randomized study (NCT03110562), which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. 0 V e h icle C trl µ M 4 . Aramchol. However, NASH resolved without fibrosis worsening in a higher proportion of patients in the 120-mg elafibranor group vs the placebo group (19% vs 12%; odds ratio = 2. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Increased ease of NASH diagnosis and treatment efficacy evaluation are critical both for patients and healthcare professionals, but also for regulatory authorities and Sep 25, 2020 · GENFIT has started the phase 3 ELATIVE clinical trial for evaluating the efficacy and safety of elafibranor for the treatment of primary biliary cholangitis (PBC). Jul 23, 2020 · France’s Genfit has said its elafibranor drug as a treatment for non-alcoholic steatohepatitis (NASH) was unable to improve patient outcomes in a phase 3 study, which has now been terminated. May 13, 2020 · In the face of a 65% drop in its Nasdaq stock price on Monday, Genfit plans to continue testing elafibranor in a different indication — the autoimmune liver disease primary biliary cholangitis — where it hopes for better results. May 11, 2020 GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH Dec 11, 2018 · Elafibranor is one of a small band of drugs barreling toward phase 3 NASH readouts. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a rare liver disease. This marks the second delay of data since September and Jun 04, 2018 · Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. SEIZURE DISORDERS A variety of seizure disorders exist, with epilepsy being the most well-known. We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic Jul 23, 2020 · Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and GENFIT’s clinical team is now fully focused on the initiation of the Phase 3 clinical trial. SG) stock discussions in Yahoo Finance's forum. genfit announces trial of elafibranor did not show significant effect on nash patients. Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens NEW YORK--(BUSINESS WIRE) November 11, 2020 -- Pfizer Inc. 04-08-2020 Full-Year 2019 Financial Results and Corporate Update May 13, 2020 · In the face of a 65% drop in its Nasdaq stock price on Monday, Genfit plans to continue testing elafibranor in a different indication — the autoimmune liver disease primary biliary cholangitis — where it hopes for better results. 7 4 0 . This phase III study is investigateing the safety and efficacy of Elafibranor against placebo in the treatment of nonalcoholic steatohepatitis and fibrosis. today announced an exclusive licensing and collaboration agreement with GENFIT (GNFT), a late-stage biopharmaceutical company Nov 16, 2020 · Sputnik V vaccine: Russia says initial results from Phase 3 trials show 92 percent effectiveness against COVID-19 The Sputnik V vaccine, developed by the Gamaleya Scientific Research Institute and the Russian defence ministry, is a two-shot vaccine. Cenicriviroc has followed a similar path, with a phase 2b leading to a phase 3 study. According to the French pharma company, ELATIVE is a randomized, double blind, placebo-controlled, global multicenter phase 3 study. It regulates lipid and insulin metabolism, two key components in the pathophysiology of NAFLD and NASH. 31; 95% confidence Phase 3 Data. Nov 13, 2018 · The results of its phase 3 trial will be available next year. As of February 2016, elafibranor has completed 8 clinical trials and a phase III is in progress. Results of the phase 3, open-label, randomized study (ALLY-3+) were published in the May issue of Hepatology. A 12 week randomized trial of twenty pediatric patients to be started at United States medical centers specializing in NASH -GENFIT partnership expands Terns’ portfolio, adding a Phase 3 product with a complementary mechanism of action well-suited to combinations with Terns’ NASH assets- FOSTER CITY, Calif. Harrison also detailed the results of a phase 2b elafibranor study that led to a registration trial that is  23 Aug 2017 These results published today in The Lancet Oncology support KYPROLIS as a superior proteasome inhibitor in relapsed multiple myeloma  After the cessation of treatment, clinical outcomes were assessed by evaluating the number of esophageal intraepithelial eosinophils, “a measure of esophageal   7 Jun 2020 In this randomized phase 3 trial, KRd did not improve PFS compared with VRd in NDMM. But with a U. Dec 03, 2018 · GENFIT's lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide ("RESOLVE-IT") in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a prevalence Apr 07, 2019 · Cara expects to announce results later this year from a phase 3 study of an intravenous (IV) formulation of the drug in treating chronic kidney disease-associated pruritis (CKD-aP) in patients on Elafibranor shows positive preliminary results Elafibranor, phase 2 trial has shown positive preliminary results in helping those PBC patients who do not respond to UDCA (Urso). Figure 8 Nov 07, 2014 · Represents earliest and most aggressive approval timelines. 2017. ’ May 12, 2020 · “The weaker the Phase 2 study design, the harsher the reality has been on Phase 3 results,” Skorney wrote, noting his team’s skepticism around results of Genfit’s Phase II GOLDEN-505 study Mar 10, 2016 · Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Sep 25, 2020 · Marinus recently reported positive Phase 3 results for ganaxolone in CDKL5 deficiency disorder In pre-market trading, the stock was adding 5. Moreo- 11 May 2020 GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis  11 May 2020 Genfit's elafibranor en route to NASH graveyard with phase 3 flop “These results are highly disappointing, not only for the Genfit team, but  Throughout the trial, patients will receive either elafibranor 120 mg or placebo once daily. PRIOR DATA/EVENTS. 2020. Day 3-5. 001), with reductions of 48% with the 80 mg/day dose, and 41% with the 120 mg Administered to over 800 patients and healthy volunteers to date, Elafibranor has demonstrated : beneficial properties for NASH : Improvement of insulin sensitivity and glucose homeostasis ; Phase 2b (GOLDEN) results were published online in GastroEnterology in February 2016 and will be fully available in the paper version in May 2016. Also in the running is French biotech Genfit, which has a phase 3 trial underway on its NASH drug hopeful, elafibranor, with results Phase 2 trial was basis for phase 3 (stage 2,3 fibrosis; 36 weeks) Thyroid hormone receptor βagonist MAESTRO-NASH Phase 3 Trial § NASH with fibrosis stage 1a, 1b, 2, 3 with NAS ≥4 and score of at least 1 in all 3 components § N=2000 § Placebo vs. As part of the deal, GENFIT and Terns will also undertake joint R&D projects in liver disease, including the development of elafibranor in combination with Jan 30, 2018 · There are others too in the Phase I and Phase II clinical trials. ADULT NASH monotherapy. Nonetheless, the efficacy of the 120-mg dose to reduce the NAS by 2 points and to improve steatosis, ballooning, and lobular inflammation was more pronounced with increasing baseline severity, in contrast to the Apr 13, 2019 · ‘Twelve weeks of elafibranor treatment was well tolerated and produced marked improvements in ALP and other biochemical markers of PBC in this Phase 2 study,’ said Dr Luketic. PHASE 3  19 Sep 2019 In Golden neither 80mg nor 120mg of elafibranor beat placebo in terms of the without fibrosis worsening, determined by Nash score and 12-month The pivotal Resolve-It trial will enrol 2,000 subjects, but it is the interim  28 Aug 2020 PDF | Background & aims: Elafibranor is an agonist of the peroxisome Results: In intention-to-treat analysis, there was no significant difference Conclusions: A post-hoc analysis of data from trial of patients with NASH  12 May 2020 The Phase 3 trial for Genfit's drug elafibranor has failed to improve outcomes for patients with the fatty liver disease NASH. 11 May 2020 French drug maker Genfit said Monday that its lead drug, elafibranor, failed to improve outcomes for patients with the fatty liver disease NASH, according to an interim analysis of a late-stage clinical trial. Nov 26, 2019 · Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Genfit has put the brakes on a late-stage trial of its experimental nonalcoholic steatohepatitis (NASH) drug elafibranor after reporting disappointing results in an interim analysis. EO (XUP. As of September 30, 2019, GNFT reports cash and cash equivalents of €303. PBC. * reg-genfit: positive outcome from the 18-month pre-planned safety review by the dsmb, in resolve-it phase 3 clinical trial with elafibranor BRIEF-Genfit completes offering of convertible bonds Apr 23, 2019 · Results showed that at the 16-week analysis, tanezumab 5mg was associated with a statistically significant improvement in pain and physical function vs NSAIDs, however patient’s overall assessment of OA was not statistically different from NSAIDs; the tanezumab 2. Complete results of the GOLDEN-505 trial were published in the  24 Jul 2020 Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and Genfit's clinical team is now fully focused on the initiation of the  11 May 2020 Today , GENFIT released the first intermediate results of their trial RESOLV'IT, ELAFIBRANOR in NASH with fibrosis. This study enrolled  Larger phase 3 trials of elafibranor in the target population of patients with Score (NAS)9 to zero without worsening in fibrosis (progression to stage 3 or 4). Risks Clinical Risks. 23 Jan 2020 In November, it reported positive safety data for elafibranor, including lack of In March, they began their first Phase 3 clinical trial, with a primary endpoint This followed positive results for lowering of liver fat in NAFLD  29 Jan 2020 Of the compounds in Phase 3 trials, only one is expected to launch in 2020, Elafibranor, under clinical investigation by Genfit in the RESOLVE-IT Phase 3 Results were confirmed by biopsy and correlated with secondary  29 Jan 2020 It was only a few years ago that a positive mid-stage clinical trial for non-alcoholic Elafibranor: Following close behind, French biotech Genfit have scheduled to release their phase 3 results in the first quarter of 2020. Elafibranor, the foremost molecule with positive outcomes on registered endpoints in Phase 2b clinical trials in adult NASH to be assessed in pediatric NASH. The phase 3 trial results are expected in early 2020 and if positive, may pave the way for FDA approval. * announced on monday interim analysis of resolve-it phase 3 trial of elafibranor did not demonstrate significant effect on primary endpoint of nash resolution without worsening of fibrosis May 12, 2020 · Of the trial, Stephen Harrison, hepatologist and medical director of Pinnacle Clinical Research in San Antonio, Texas, said, “NASH is a complicated, heterogeneous disease, and the results of the RESOLVE-IT Phase III study of elafibranor in NASH demonstrate this significant hurdle. Elafibranor. Pre-clinical studies Elafibranor has shown promising anticholestatic effects in a Phase II clinical trial, while showing a trend in reducing pruritus. High-fat diet (HFD)-induced steatohepatitis and CKD share common pathogenesis involving peroxisome proliferator-activated receptor (PPAR)-<i>α</i> and -<i>δ</i>. PHASE 3 INTERIM RESULTS – 1Q20. We are lowering our PT to $70 driven by reduction in annual cost for elafibranor to €7k given more pricing-pressure in the macro-environment. It is then that Elafibranor attained the FDA recommended endpoint of “NASH Resolution without the worsening of Fibrosis. 09-30-2020 First Half-Year 2020 Financial Report and New Corporate Strategy. Results: In intention-to-treat analysis, there was no significant difference between the elafibranor and placebo groups in the protocol-defined primary outcome. Elafibranor concentration (µ. 2 | Elafibranor Elafibranor is a peroxisome proliferator-activated receptor alpha-delta α/δ agonist. & SHANGHAI–(BUSINESS WIRE)–Jun. 61% to $11. Aldafermin. LDH (day 2, 5 and 7) A. 00 52-Week Low $0. This would be the basis for seeking approval to market the drug. Jul 22, 2020 · Genfit bails on elafibranor in NASH As many expected after announcing negative interim results on May 11, Genfit (NASDAQ: GNFT ) has decided to discontinue the Phase 3 RESOLVE-IT study evaluating elafibranor in patients with nonalcoholic steatohepatitis (NASH). Day 6-7. B. listing in the works, the PBC readout gives Genfit a chance to show its fate is tied to more than just those results. About NASH Vehicle Ctrl 1 . A number of phase 3 clinical trials are currently ongoing including Elafibranor, a dual PPAR α/δ agonist, Cenicriviroc, a CCR2/CCR5 chemokine antagonist, the nuclear bile acid receptor FXR agonist obeticholic acid, Aramchol, a fatty acid bile acid conjugate that modulates SCD-1, and Resmetrion, a liver-specific THR-β agonist. Nov 13, 2020 · The Phase 3 BOSTON Study Results as Published in the Lancet. 2020-10-01: Phase 3: NCT03689712 The absence of safety concern has been confirmed in a full toxicological package up to 2-year carcinogenicity studies. 16 hours ago · With November bringing encouraging results on vaccine trials, focus must now shift to rapidly expand the infrastructure needed for vaccine delivery. 8 mg/day[2] Obeticholic Acid 25 mg/day[3] Elafibranor 120 FDA authenticates study protocol, giving go-ahead for GENFIT to begin a Phase II clinical trial in pediatric NASH. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. Additionally, a Mar 11, 2019 · GENFIT's lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 clinical trials worldwide ("RESOLVE-IT") in nonalcoholic May 12, 2020 · “We are not terribly surprised elafibranor failed in the RESOLVE-IT Phase 3 study in NASH as we were pretty skeptical ahead of results based on our diligence into elafibranor’s Phase 2 data Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a severe liver disease. Mar 16, 2020 · • ALT-801 preclinical results showed superior reductions in nearly all measured NASH parameters compared to semaglutide or elafibranor, returning many parameters to lean normal range: • Body and liver weight • NAS and ALT • Collagen (COL1A1 and galectin-3) content • Liver fat, cholesterol and triglycerides This review discusses completed phase II randomized clinical trials with high-quality published results for compounds that demonstrate effects on nonalcoholic steatohepatitis histology (obeticholic acid, elafibranor, and liraglutide). In Vitro Effects of Elafibranor in HFD-Sera-Pretreated Podocyte/HK-2 Cells Sep 16, 2020 · China and the United Arab Emirates have seen some positive results in their Phase III COVID-19 vaccine trials, Chinese foreign ministry spokesman Wang Wenbin told a news briefing in Beijing on Monday. pa>::announced on monday interim analysis of resolve-it phase 3 trial of Ratziu V,etal. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH. An equally important aspect when treating patients with NASH is the requirement for absence of deterioration (or at best improvement) of the cardiometabolic A Phase 3 clinical trial expected to be initiated in 2019. Elafibranor evidenced positive results in the targeting of PBC—both primary and secondary endpoints met Nov 26, 2019 · Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Jul 23, 2020 · Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and GENFIT’s clinical team is now fully focused on the initiation of the Phase 3 clinical trial. RESOLV'IT is a  ELAFIBRANOR AMAZING RESULTS IN PBC. An equally important aspect when treating patients with NASH is the requirement for absence of deterioration (or at best improvement) of the cardiometabolic Jul 22, 2020 · Elafibranor demonstrated promising results in a Phase 2 clinical trial for PBC and GENFIT's clinical team is now fully focused on the initiation of the Phase 3 clinical trial. Identification of new pharmacological approaches to inhibit the excessive fat intake-induced steatohepatitis and chronic kidney disease (CKD) is important. Gastroenterology. Elafibranor, a dual PPAR<i>α</i>/<i>δ</i> agonist, can ameliorate the HFD Aug 10, 2018 · The timeframe is vitally important, considering the failure of Genfit’s elafibranor to hit 12-month fibrosis and Nash clearance endpoints in phase II. Intrahepatic drug targets in phase 2 and 3 clinical trials for NASH. This is because Elafibranor is the most advanced drug in this category. Investor confidence in the drug has waned over time, especially in the last year as the company announced delays to the Phase 3 data reveal. Nov 16, 2020 · a 3-year deferral of the maturity date (until October 16, 2025) which would reduce the financial pressure on the Company and give it the flexibility to decide on the optimal strategy to monetize results of the Phase 3 clinical trial ELATIVE™ evaluating elafibranor in PBC: direct commercial development or through partnerships, strategic Jul 23, 2020 · Genfit went beyond ending the Phase 3 trial of elafibranor in NASH patients. About RESOLVE-IT RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Dec 06, 2018 · GENFIT’s lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a Dec 07, 2015 · The next much anticipated step in this race was the announcement of Phase 3 trials: In September 2015, Intercept officially started its Phase 3 trial of obeticholic acid, or OCA, while Genfit announced recently the design of its own Phase 3 trial to start before the end of the year with its leading compound, elafibranor. Nov 16, 2015 · Thus, the design of the Phase 3 trial is optimal to confirm the good efficacy/safety ratio of Elafibranor on resolution of NASH at an interim analysis after 72 weeks, and on prevention of Sep 24, 2020 · Elafibranor, currently in a phase 3 clinical trial for PBC (ELATIVE), has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted Breakthrough Therapy INTERIM RESULTS . The company said it would now embrace a new corporate strategy, details of which will be announced in September, that Jul 22, 2019 · Elafibranor has also been shown to increase high-density lipoprotein levels, which may provide additional cardiovascular benefits. Now, as part of its half-year 2020 financial report, the company announced significant restructuring that will include cutting 40% of its staff. After completion of the double blind period, participants will be offered the opportunity to enter an open label long term extension study for up to 5 years. Topline interim results of Genfit’s Phase III study RESOLVE-IT are expected by the end of 2019. If we limit the examination of the NASH pipeline to drugs that have advanced to phase 3 stages of trials in the United States, we are left with only 3 agents: obeticholic acid (OCA), elafibranor, and aramchol. May 14, 2019 · Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a rare liver disease. pa>::announced on monday interim analysis of resolve-it phase 3 trial of Sep 26, 2019 · Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. PPAR α/δ. Nov 22, 2017 · Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. pa>::announced on monday interim analysis of resolve-it phase 3 trial of GENFIT: Reports Third Quarter 2019 Financial Information (Unaudited financial information under IFRS) Cash and cash Nov 07, 2014 · Represents earliest and most aggressive approval timelines. Jul 23, 2020 · Elafibranor showed promising results in a Phase II clinical trial for PBC and was granted Breakthrough Therapy designation by the U. 2022+ 2022+ Launch. Lipotoxicity, typically occurring in NASH, can evoke ER-stress and the unfolded protein response (UPR) [3] , [4] . We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic Sep 24, 2020 · Elafibranor, currently in a phase 3 clinical trial for PBC (ELATIVE), has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted Breakthrough Therapy designation by the FDA and Orphan Drug designation by the FDA and EMA in this condition. Stong ALP/composite results further justify moving Elafibranor onto a phase 3 trial in PBC patients with 2018 Half-Year Results: Cash Position at End of Period at €238M and Significant Advances in the Clinical Development of Elafibranor - Completion of enrollment of approx. 2019. may 12 (reuters) - genfit sa <gnft. Increased ease of NASH diagnosis and treatment efficacy evaluation are critical both for patients and healthcare professionals, but also for regulatory authorities and Interim Results The RESOLVE-IT Phase III trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4, fibrosis stage 2 or 3. 2018. In this phase 2 study, Luketic and Future phase 3 trials will evaluate the effect of elafibranor on the rate of progression to cirrhosis as a result of the resolution of NASH or also through a direct anti- fibrotic effect. Jul 02, 2018 · Figure 17: Elafibranor for NASH - SWOT analysis Figure 18: Datamonitor Healthcare's drug assessment summary of elafibranor in NASH Figure 19: Datamonitor Healthcare's drug assessment summary of elafibranor in NASH Figure 20: Elafibranor sales forecast for NASH across the US and five major EU markets, by country, 2016-25 May 28, 2018 · Phase 2b (GOLDEN) results were published online in Gastroenterology in February 2016 and will be fully available in the paper version in May 2016. 6 The results of the use of elafibranor on the liver-related traits, including histological and biochemical pa-rameters, and also on the metabolic-associated risk factors are certainly promising as summarized in table 1. A. Despite the problems experienced by other late-stage contenders in this space and indeed the debated success of Genfit’s own phase II study of elafibranor in NASH in 2015, Hum seems Nov 16, 2020 · Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. Nov 26, 2019 · Elafibranor has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted the Breakthrough Therapy Designation by the FDA in this indication. Elafibranor: Elafibranor (also known as GFT505) is a dual PPAR-α/δ agonist produced by GENFIT (Loos, France) that is currently undergoing evaluation in the phase 3 RESOLVE-IT trial (NCT02704403). There is no guarantee that the Phase 3 RESOLVE-IT NASH trial based upon predictions from elafibranor 80 mg n = 93, and elafibranor 120 mg n = 91) international phase II randomized trial of patients with NASH. elafibranor phase 3 results

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