Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH

• 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 900 patients randomized in the main and exploratory cohorts, including more than 360 and 80 patients that have been treated for more than 48 and 72 weeks, respectively.
• The patient who experienced the adverse event of increased liver test results, which was reported as a SUSAR, has been without clinical symptoms throughout the period of observation and has fully recovered.
• The DMC review confirms the good safety profile of lanifibranor.

Daix (France), Long Island City (New York, United States), May 16, 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 fourth scheduled meeting of the Data Monitoring Committee (“DMC”) to continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients with MASH/NASH without modification to the current trial protocol.

The DMC, composed of a group of independent experts, conducted its review based on the unblinded safety data from more than 900 patients randomized in the main cohort, which includes patients with MASH/NASH and fibrosis stage F2 and F3, and in the exploratory cohort, which includes patients with MASH/NASH and fibrosis stage F1 through F4 who are histologically not eligible for the main cohort.
Among the more than 900 patients whose data was reviewed, over 360 patients have been treated for more than 48 weeks and 80 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.