Inventiva announces DMC recommendation to continue NATiV3 trial as is

Inventiva (IVA) announced the recommendation from the fifth scheduled meeting of the Data Monitoring Committee, or 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.