GENFIT announced on 4/23/18 that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH without any modifications.
The finding is important because NASH is a chronic disease and patients need to be able to tolerate the treatment for long periods. Several of the leading candidates seeking approval for NASH treatment have serious safety risks.
The race to be the first to receive approval for a NASH indication is fierce. The eventual market for this complex disease is forecast to be $20 billion to $35 billion.
In a Ph II trial published in Gastroenterology in 2016, elafibranor did not meet its original primary endpoint. However, based on a modified definition of the endpoint, elafibranor did outperform placebo.
