Hepion Pharmaceuticals Gets Fast-Track Designation for NASH Treatment
By Chris Wack
Hepion Pharmaceuticals Inc. said the U.S. Food and Drug
Administration has granted Fast Track designation for its lead drug
candidate, CRV431, for the treatment of non-alcoholic
The FDA Fast Track designation allows sponsors to gain access to
expedited drug approval reviews for medical conditions that are
serious and potentially life-threatening, and where there is an
unmet medical need. The program is also designed to facilitate drug
development by making provisions for more frequent meetings with
the FDA to discuss drug development plans, and Fast Track
designation can lead to Accelerated Approval and/or Priority Review
eligibility if certain criteria are met.
The biopharmaceutical company said that administered once daily
as an oral soft gel capsule, CRV431 has been well-tolerated and has
shown signals of efficacy in NASH in an early Phase 2 study. It
plans to start a larger Phase 2b NASH study in biopsy confirmed F2
and F3 NASH subjects in the coming months.
Hepion shares were up 9% to $1.35 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
November 30, 2021 08:31 ET (13:31 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.