FDA grants fast track designation to CRV431 for NASH treatment
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The FDA granted fast track designation to CRV431, a potent cyclophilin inhibitor, for the treatment of patients with nonalcoholic steatohepatitis, according to a release from Hepion Pharmaceuticals.
The designation allows sponsors to access drug approval reviews for serious and potentially life-threatening medical conditions and where there is an unmet need, according to the release.
“We are keenly aware that there remains an urgent global need to develop NASH-specific therapeutic drugs for this potentially life-threatening condition for which there are currently no FDA-approved drugs,” Todd Hobbs, MD, chief medical officer for Hepion, said in the press release. “Furthermore, the American Liver Foundation estimates that at least 5% of the U.S. adult population has NASH. As such, we are very pleased to receive the FDA’s fast track designation and are looking forward to working closely with the agency as we advance development of CRV431.”
According to Hobbs, CRV431 underwent investigation among healthy patients during Hepion’s phase 1 program and, more recently, among patients with presumed stage F2 and F3 NASH in its phase 2a study. The oral soft gel capsule was administered once daily and was well tolerated, showing signals of efficacy in NASH.
“This fast track designation provides for early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to a more expedited drug approval and patient access to CRV431,” Robert Foster, PharmD, PhD, CEO for Hepion, said in the release.
Hepion aims to initiate a larger phase 2b study among patients with biopsy-confirmed NASH.
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