Drug news
Data Safety Monitoring Board positive recommendation for RESOLVE-IT Phase III trial of elafibranor to proced for NASH.- Genfit.
GENFIT announced that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation of the RESOLVE-IT Phase III trial evaluating elafibranor in NASH without any modifications. NASH being considered as a chronic condition, safety is crucial for any drug candidate aiming to address the unmet clinical needs related to this pathology. The positive outcome of this safety review by the DSMB allows GENFIT to actively pursue its effort in enrolling patients and continuation of the RESOLVE-IT trial, which has already recruited the cohort needed for the interim analysis required for accelerated market approval.