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Lanifibranor phase 2 results

NASH - January 2021 NASH - January 2021 Inventiva announced design of Phase 3 clinical trial with lanifibranor in NASH 06 Jan 2021Inventiva - Lanifibranor (pan-PPAR agonist, Phase 3)Inventiva planned a single global Phase 3 (NATIVE3) trial evaluating two doses of lanifibranor (800 mg and 1200 mg once daily) versus placeboTrial design and clinical strategy was discussed with both FDA and EMA.
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Apr 06, 2018 · On Wednesday, Inventiva announced its selection of lanifibranor for a Phase 2 investigator-initiated clinical trial for a possible treatment for patients with non-alcoholic fatty liver disease in patients with type 2 diabetes (T2DM). The study will be conducted by Kenneth Cusi, MD, Chief of the Division of Endocrinology, Diabetes & Metabolism .... Oct 20, 2021 · With these latter results, lanifibranor is the first orally available drug candidate to achieve statistically significant results on the two U.S. Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking U.S. accelerated approval and EU conditional approval during Phase III clinical development..
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part 1 of the Phase III clinical trial of lanifibranor in patients with NASH and two Phase II trials in patients with NAFLD and type 2 diabetes, and in combination with empagliflozine, pipeline and preclinical and clinical development plans, milestone payments, royalties and product sales, future. A SECOND ANALYSIS ON THE INTERCEPT PHASE 2 ON NASH IN JAPAN (by Gery DIVRY) ... OCALIVA INTERMEDIATE RESULTS OF PHASE 3, QUICK ANALYSIS; GILEAD's POSSIBLES STRATEGIES IN NASH (updated february 2019) ... (GENFIT): PPAR alpha delta, in phase 3. LANIFIBRANOR (INVENTIVA): PPAR alpha delta gamma, in phase 2b. SAROGLITAZAR (ZYDUS): PPAR alpha gamma.

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CENTAUR is a large phase IIb trial that investigated the effectiveness of cenicriviroc (CVC), a dual C-C chemokine receptors 2 and 5 antagonist, for the treatment of NASH with fibrosis. In this 2-year study, adults with NASH and fibrosis stages 1-3 were enrolled and randomized to receive 150 mg of CVC or placebo once daily for 1 year.

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Nonalcoholic Steatohepatitis - Opportunities and Challenges- A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH - (10/25/21) ... Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis.
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Low-dose lanifibranor achieved the same outcome in 39% of subjects, while 22% of subjects receiving a placebo achieved NASH resolution without worsening fibrosis. 25 A Phase III trial on oltipraz by South Korean company Pharmaking was estimated to be completed in October 2021. 26.

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Lanifibranor is the first drug candidate to achieve statistically significant results on the USA FDA and European Medicine Agency (EMA) primary endpoints. 37 Thus, outcomes relevant for seeking accelerated approval during future phase III RCTs with a longer duration of follow-up are ongoing.
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In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of adult patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

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NASH Clinical Trials. Non-alcoholic Steatohepatitis studies recruiting patients for novel treatments. Filter by phase, distance, and inclusion criteria to find your perfect nash clinical trial. Clinical Trials NASH Clinical Trials. 1. Effectiveness. 2.
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Cash position2 at €80.5m as of March 31, 2022The Group did not generate any revenue in Q1 2022Signature of a €50 million bullet credit facility agreement with the European Investment BankUpdate on lanifibranor recruitment timing for Phase III trial in patients with NASH, as well as for the two Phase II trials in patients with NAFLD and type 2 diabetes, and in.

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Sep 20, 2021 · Company to host Virtual Investor Event on September 20, 2021 at 8:30 a.m. ET / 5:30 a.m. PT Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced positive topline results from the potentially registration-enabling cohort of the Phase 2 KRYSTAL-1 study, evaluating adagrasib in patients with advanced non-small cell lung cancer (NSCLC) harboring the ....

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Jan 25, 2021 · As noted, promising Phase II results for NASH therapies have not always been borne out in larger trials. Another PPAR agonist, elafibranor—which targets the alpha and gamma types but not delta—also produced NASH resolution without worsening of fibrosis in about 20% of participants and reduced liver enzymes and inflammation biomarkers in a Phase II study..
Im Rahmen der NATIVE Studie wurde Lanifibranor bei 247 Patienten mit höhergradiger Fibrose und hochaktiver NASH in Dosierungen von 800 oder 1200 mg/d gegenüber einer Placebogabe über 24 Wochen verglichen. Die Ergebnisse wurden auf dem digitalen amerikamenischen Leberkongress (TLMdX 2020) berichtet. ... Results of the native phase 2b trial.
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Landos' lead clinical asset, BT-11, is a first-in-class, oral therapeutic that acts locally in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD). The company has completed Phase 1 clinical testing, initiated Phase 2 clinical testing of BT-11 for ulcerative colitis and plans a Phase 2 trial in Crohn's disease in 2019.

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Anticipated timing for data readouts for the Phase II trial of lanifibranor in NAFLD patients with type 2 diabetes (T2D) and for the Phase II LEGEND trial combining lanifibranor with SGLT2.

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Pierre Broqua, CSO and cofounder of Inventiva, stated: "We are very pleased with this decision following the positive results of lanifibranor during the Phase IIb clinical trial in NASH. Type 2 diabetes patients with NASH are generally exposed to an increased risk of poor clinical outcomes and are therefore in a critical need for an.

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The initiation of the is planned for H1 202trial 2 and the publication of topline results is expected for H2 2023 . Daix (France), Long Island City (New York, United States) ... the heterogeneity of patients and the results of our Phase IIb trial with lanifibranor in. Mar 08, 2022 · The planned Phase II trial, LEGEND3, has been designed as a multi-center randomized, placebo-controlled proof-of-concept trial to assess the safety and efficacy of lanifibranor in combination with ....

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Redirecting to /results-from-inventivas-phase-2b-native-trial-of-lanifibranor-in-treating-nash-published-in-the-new-england-journal-of-medicine (308).
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Feb 20, 2019 · The FASST clinical trial, a one-year, double-blind, randomized, placebo-controlled Phase IIb study, included 145 patients suffering from the early phase of dcSSc, who received lanifibranor in either two doses of 400mg per day or two doses of 600mg per day over 48 weeks in addition to their existing standard of care, which in most cases included ....
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Lanifibranor is now part of a phase IIb trial in patients with NASH without cirrhosis. To date, significant reductions in steatohepatitis, regression of fibrosis and improved glycaemic control and lipid profile have been reported [ [ 272 ] ], suggesting pan-PPAR agonism could have a strong therapeutic potential and be a promising therapeutic.

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A single-phase trinary asymmetrical cascaded H-bridge (TACHB) inverter with a level doubling network (LDN) is proposed in this paper. It consists of a LDN and ‘n’ H bridges, where ‘n’ represents the number of DC sources. The TACHB-LDN generates N number of levels at the output voltage using $${\\mathrm{log}}_{3}\\left(\\frac{N+1}{2}\\right)$$ log 3 N + 1 2 DC. part 1 of the Phase III clinical trial of lanifibranor in patients with NASH and two Phase II trials in patients with NAFLD and type 2 diabetes, and in combination with empagliflozine, pipeline and preclinical and clinical development plans, milestone payments, royalties and product sales, future.
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European Medicines Agency -.

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Abstract #2: "Lanifibranor therapy reduces the FibroScan-aspartate aminotransferase ... including for part 1 of the Phase III clinical trial of lanifibranor in patients with NASH and two Phase II trials in patients with NAFLD and type 2 diabetes, ... Actual results may turn out to be materially different from the anticipated future results.

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A SECOND ANALYSIS ON THE INTERCEPT PHASE 2 ON NASH IN JAPAN (by Gery DIVRY) ... OCALIVA INTERMEDIATE RESULTS OF PHASE 3, QUICK ANALYSIS; GILEAD's POSSIBLES STRATEGIES IN NASH (updated february 2019) ... (GENFIT): PPAR alpha delta, in phase 3. LANIFIBRANOR (INVENTIVA): PPAR alpha delta gamma, in phase 2b. SAROGLITAZAR (ZYDUS): PPAR alpha gamma.

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Francque et al. have recently published the results of the Phase 2b trial with the pan-PPAR (PPAR-α/γ/δ) agonist Lanifibranor [Phase 2b Study in NASH to Assess IVA337 (NATIVE), NCT03008070] (6). The study included 247.
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Activation of first clinical sites and start of patient screeningThe two-part NATiV3 Phase III clinical trial will evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosisThe primary endpoint of the trial's part 1 will evaluate the response to the treatment defined by both resolution of NASH and.

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