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FDA approves IND for elafibranor for primary biliary cholangitis
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GenFit announced the FDA has cleared its investigational new drug application for elafibranor, which will now be investigated in a phase 2 clinical trial for the treatment of primary biliary cholangitis.
The objective of the phase 2 clinical trial is to determine the safety and efficacy of daily oral administration of elafibranor (GenFit) on alkaline phosphatase levels compared with placebo for 12 weeks. All patients in the trial will have PBC and had a failed response to prior therapy with ursodeoxycholic acid, per a press release.
“We are satisfied with the progress made on the regulatory side in PBC,” Jean-François Mouney, CEO, co-founder, and chairman of the board of GenFit, said in the release. “We soon hope to be able to provide patients with a new, safe and well-tolerated therapeutic solution.”
In a separate phase 2 clinical trial, elafibranor demonstrated substantial histological improvement in nonalcoholic steatohepatitis, including resolution of steatohepatitis, and improvement of the cardiometabolic risk profile without worsening fibrosis, among patients with NASH.
Disclosure: Mouney is employed by GenFit.