The FDA granted Hepion Pharmaceuticals (NASDAQ:HEPA) fast track designation for its lead drug candidate, CRV431, for the treatment of non-alcoholic steatohepatitis (NASH).
CRV431 has been investigated in healthy subjects during Hepion’s Phase 1 program, and more recently in subjects with presumed F2 and F3 NASH in the Phase 2a AMBITION study.
“Administered once daily as an oral soft gel capsule, CRV431 has been well-tolerated and has shown signals of efficacy in NASH in the early Phase 2 study,” Todd Hobbs, M.D., Hepion’s CMO, said in a statement.
“We are now looking forward to initiating our larger Phase 2b NASH study, called ASCEND-NASH, in biopsy confirmed F2 and F3 NASH subjects in the coming months,” he added.
Dr. Hobbs also said 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. The American Liver Foundation estimates that at least 5% of the U.S. adult population has NASH.
Robert Foster, PharmD, Ph.D., Hepion’s CEO, said 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.
In addition, as part of the FDA fast track designation for CRV431 in NASH, Hepion will make its expanded access policy publicly available in the coming weeks, he added.