French late-stage biopharmaceutical firm Genfit has received a positive recommendation from the data safety monitoring board (DSMB) to continue the Phase III Resolve-IT study of Elafibranor in nonalcoholic steatohepatitis (NASH).
The 42-month DSMB safety review supports the continuation of the Resolve-IT multicenter, randomised, double-blind, placebo-controlled study, which will assess the efficacy and safety of 120mg elafibranor versus placebo in patients with NASH and fibrosis.
The study has two arms and is carried out under Subpart H (FDA) and conditional approval (EMA).
Genfit plans to announce top-line interim results from the study in the first quarter of next year. The company aims to file for US Food and Drug Administration (FDA) and European Medicines Agency approval by the end of 2020 if they are positive.
If approved, elafibranor would be the first drug to secure approval for the resolution of NASH without the worsening of fibrosis.
The FDA had already granted fast track designation to elafibranor for the treatment of NASH, which is believed to affect around 12% of people in the US.
Genfit chief medical officer Carol Addy said: “This seventh, favourable DSMB review is further confirmation that our Resolve-IT trial can continue without modification, keeping us on track for an NDA filing by the end of 2020.
“It strengthens our confidence that elafibranor is generally safe and well tolerated, which is paramount for drugs that are intended to treat a chronic and silent disease, such as NASH. We hold great hope for elafibranor based upon safety and efficacy data in the Golden-505 study and based upon available safety data from the ongoing Phase III Resolve-IT trial.”
Elafibranor is an oral, once-daily drug acting through dual agonism of peroxisome proliferator-activated alpha/delta receptors.
In Phase II clinical trial results, elafibranor was found to be an effective treatment for PBC, a chronic liver disease.