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- Inventiva's lanifibranor became the first drug to simultaneously achieve NASH resolution and fibrosis improvement endpoints in a phase 2b trial, with 45% of patients resolving NASH at high dose versus 19% on placebo. - Jefferies analysts raised peak sales projections to $2.6 billion annually following the positive trial results, which demonstrated significant improvements in both inflammation resolution and liver scarring reduction. - The company's phase 3 NATiV3 trial is fully enrolled with 1,009 patients in the registrational cohort, targeting an addressable U.S. F2/F3 MASH population of approximately 375,000 patients. - Top-line results from the phase 3 trial are expected in the second half of the year, with potential market launch by 2025 if trials prove successful.
- The FDA has accepted Echosens' Letter of Intent to qualify liver stiffness measurement by FibroScan® as the first non-invasive surrogate endpoint for MASH clinical trials. - This milestone could replace invasive liver biopsies for patient enrollment and treatment response assessment in MASH drug development programs. - The acceptance is supported by over 5,600 peer-reviewed publications and endorsements from major pharmaceutical companies including Eli Lilly, Boehringer Ingelheim, and Novo Nordisk. - The development has the potential to accelerate drug development by improving trial recruitment and patient retention while reducing patient burden.
- Inventiva has appointed Dr. Jason Campagna as President of R&D and Chief Medical Officer to lead the development of lanifibranor, a first-in-class pan-PPAR agonist for MASH treatment. - Dr. Campagna brings extensive experience from Intercept, where he led the first-ever NDA submission for MASH indication and designed advanced clinical programs. - Dr. Martine Zimmermann joins as Executive Vice President of Regulatory Affairs and Quality Assurance, bringing expertise in global regulatory strategy for chronic liver diseases. - The appointments come as Inventiva advances lanifibranor through the pivotal Phase 3 NATiV3 trial, with topline results expected in the second half of 2026.
- Inventiva received a $10 million milestone payment from CTTQ following successful completion of the second tranche of its €348 million structured financing program. - The payment stems from a licensing agreement for lanifibranor, a pan-PPAR agonist with Breakthrough Therapy Designation for MASH treatment in both the US and China. - CTTQ has joined Inventiva's ongoing NATiV3 Phase 3 trial with over 60 sites in mainland China and completed a Phase I bridging study confirming no ethnic differences. - Under the partnership, Inventiva remains eligible for up to $265 million in additional milestone payments plus low single-digit royalties on net sales if approved.
- Inventiva published results in Journal of Hepatology Reports showing lanifibranor reduced liver sinusoidal endothelial cell capillarization in MASH patients during the Phase 2b NATIVE trial. - The study demonstrated that LSEC capillarization occurs early in disease progression and correlates strongly with liver fibrosis and inflammation severity. - Preclinical models revealed lanifibranor's effects extend beyond capillarization reversal, normalizing portal pressure and intrahepatic vascular resistance superior to single PPAR agonists. - These findings support lanifibranor's potential as a comprehensive therapeutic approach for preventing MASH progression to cirrhosis through its pan-PPAR agonist mechanism.
- Over 80 companies are actively developing treatments for Non-Alcoholic Steatohepatitis (NASH), with Inventiva Pharma and Cirius Therapeutics leading with Phase III candidates lanifibranor and MSDC-0602K respectively. - Lanifibranor, a triple PPAR agonist with FDA Breakthrough Therapy designation, demonstrates significant anti-inflammatory and antifibrotic properties, while MSDC-0602K selectively modulates the mitochondrial pyruvate carrier to improve metabolic parameters. - Novel therapeutic approaches include Terns Pharmaceuticals' THR-β agonist TERN-501 and HighTide Biopharma's HTD1801, both showing promising results in reducing liver fat and improving metabolic markers in Phase II trials.
• Inventiva and Hepalys Pharma have initiated the clinical development of lanifibranor in Japan, dosing the first participant in a Phase 1 trial to evaluate safety, tolerability, and pharmacokinetics. • The study will involve 32 subjects across four cohorts receiving daily lanifibranor doses for 14 days, marking a crucial step toward potential MASH treatment in the Japanese market. • Positive results could lead to a pivotal Phase 3 trial in Japan, where approximately 2.7% of the population suffers from MASH, representing a significant market opportunity.
• Inventiva announces major restructuring, including significant workforce reduction and termination of preclinical programs, to extend financial runway through critical Phase III trial completion. • The company's strategic realignment focuses resources on lanifibranor, their lead candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH), with pivotal data expected in H2 2026. • This cost-cutting initiative aims to ensure the company can reach the crucial Phase III data readout milestone for lanifibranor without compromising the trial's execution.
• French biotech Inventiva announces major restructuring, planning to lay off 50% of employees and discontinue all preclinical research except for its lead MASH candidate lanifibranor. • Company's Phase III trial for lanifibranor in MASH has achieved over 95% patient randomization, with top-line results expected in second half of 2026. • Strategic financial moves, including structured financing and milestone payments, combined with cost-cutting measures, expected to extend operations through Q3 2026.
- Inventiva announces strategic pipeline prioritization, halting all preclinical research to focus exclusively on lanifibranor development for MASH treatment, with planned 50% workforce reduction. - Company reports €96.6 million cash position at 2024 year-end, securing operations until Q3 2025, with potential additional funding of €116 million expected in Q2 2025. - Last patient screening completed in NATiV3 Phase 3 trial of lanifibranor, with final patient randomization expected in first half of 2025 and topline results anticipated in second half of 2026.
