Inventiva announces the positive recommendation of the fifth DMC of the NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH
- The Data Monitoring Committee recommended to continue the clinical trial without modification of the current protocol, based on the pre-planned review of safety data.
- The recommendation was based on the unblinded review by the DMC of safety data from more than 1000 patients randomized in the main and exploratory cohorts, including over 800 and 170 patients that have been treated for more than 24 and 72 weeks, respectively.
- This fifth DMC review confirms the good safety profile of lanifibranor.
Daix (France), Long Island City (New York, United States), November 30, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other diseases with significant unmet medical needs, today announced the positive recommendation from the fifth scheduled meeting of the Data Monitoring Committee ("DMC") to continue the NATiV3 Phase 3 clinical trial evaluating lanifibranor in patients with MASH without modification to the current trial protocol.
The independent group of experts conducted its review based on the unblinded safety data from more than 1000 patients randomized in the main cohort and in the exploratory cohort.
Among the more than 1000 patients whose data was reviewed, over 800 patients have been treated for more than 24 weeks, the treatment duration evaluated in the Phase 2b, NATIVE, study, and 177 patients have been treated for more than 72 weeks. The safety data was unblinded to the DMC but remains blinded with respect to the Company. The DMC review supports the continuation of the NATiV3 clinical trial without modification to the current trial protocol. This positive recommendation confirms the good safety and tolerability profile of lanifibranor.
About lanifibranor
Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor ("PPAR") isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH. Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH, a common and progressive chronic liver disease.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva's decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris ((ticker: IVA, OTC:IVEVF) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
Contacts
| Inventiva Pascaline Clerc EVP, Strategy and Corporate Affairs [email protected] +1 240 620 9175 | Brunswick Group Tristan Roquet Montegon / Aude Lepreux / Matthieu Benoist Media relations [email protected] +33 1 53 96 83 83 | ICR Healthcare Patricia L. Bank Investor relations [email protected] +1 415 513-1284 |
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