ContraVir Pharmaceuticals (NASDAQ:CTRV) filed an IND with the FDA for CRV431 for the treatment of non-alcoholic steatohepatitis (NASH).
CRV431, a cyclophilin inhibitor, is being developed for fibrosis and other liver diseases, including hepatitis B virus (HBV). ContraVir’s proposed IND opening study is designed to characterize the anti-fibrotic effects of CRV431 monotherapy in NASH patients.
The study will enroll eight patients with mild, eight patients with moderate, and eight patients with severe hepatic impairment; and up to 24 healthy subjects to serve as the control group.
“This submission follows our compelling and positive preclinical and clinical work conducted to date, indicating that CRV431 offers a novel approach to treating NASH, with broader applications in liver disease,” Dr. Robert Foster, ContraVir’s CEO, said in a statement.
ContraVir previously submitted an IND for CRV431 for the treatment of HBV. The company has completed two Phase 1 trials that confirmed CRV431’s safety and tolerability, as well as its pharmacokinetic profile when administered alone and with tenofovir disoproxil fumarate, an antiretroviral drug. ContraVir is currently conducting a 28-day multiple ascending dose Phase 1 study of CRV431 for HBV.
