Dosing is underway in an open-label Phase 2 clinical trial, AMBITION, evaluating Hepion Pharmaceuticals’ (NASDAQ:HEPA) lead drug CRV431 in patients with F2 (moderate fibrosis) or F3 (advanced fibrosis) nonalcoholic steatohepatitis (NASH).
The primary endpoints of the 18-subject study are safety, tolerability, pharmacokinetic and pharmacodynamic measures. The secondary endpoint is the change from baseline in anti-fibrotic markers.
The estimated primary completion date is October.
The company says CRV431 inhibits a family of proteins called cyclophilins that play key roles in a range of cellular functions. It is also being investigated as a treatment for HBV infection.
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