ContraVir Pharmaceuticals (NASDAQ:CTRV) reported that the FDA provided positive feedback to the company’s pre-IND meeting regarding CRV431 for the treatment of non-alcoholic steatohepatitis (NASH).
CRV431 is a cyclophilin inhibitor being developed for NASH, the more severe form of non-alcoholic fatty liver disease. The candidate is also in Phase 1/2a clinical trials for hepatitis B.
The FDA supported ContraVir’s development plans for CRV431 in the NASH indication, including additional preclinical studies and the design of the NASH IND opening study.
“We intend to continue our thorough examination of additional models, both in vitro and in vivo, to support our push to Phase 2 clinical trials,” Dr. Robert Foster, ContraVir’s CEO, said in a statement.
“We have generated compelling and consistent anti-fibrotic data from five separate studies in two different animal models and believe CRV431 holds great promise for this indication. More recently, we also demonstrated positive activity in precision cut human liver slices. Liver fibrosis is a very harmful feature of NASH, and the anti-fibrotic mechanism of CRV431 differentiates it from most drugs in development for NASH,” he added.