Inventiva positive recommendation of 4th DMC of Phase III trial with lanifibranor in 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.

https://www.globenewswire.com/news-release/2024/05/16/2883850/0/en/Inventiva-announces-the-positive-recommendation-of-the-fourth-DMC-of-the-NATiV3-Phase-III-clinical-trial-with-lanifibranor-in-patients-with-MASH-NASH.html