ContraVir Pharmaceuticals Receives Positive FDA Response To CRV431 Pre-IND Package For NASH
GlobeNewswire - Thu Jun 20, 3:30PM CDT
ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH") and chronic viral infection, today announced positive feedback from the U.S. Food and Drug Administration ("FDA") in response to ContraVir's pre-Investigational New Drug ("pre-IND") meeting with respect to the development of CRV431 in NASH.
The FDA provided positive feedback on ContraVir's existing preclinical data of CRV431 and supports the study design for the NASH IND opening study. The FDA also concurred with the company's proposed plan for further preclinical studies to support the development of CRV431. Overall, the FDA supported ContraVir's clinical development plans for CRV431 in the NASH indication.
"We are pleased with the FDA's positive feedback on the preclinical work we've completed to-date, as well their feedback on additional planned studies that will support an IND submission for CRV431 in NASH. This IND submission for NASH will be in addition to our current existing IND for hepatitis B virus treatment," said Dr. Robert Foster, Chief Executive Officer of ContraVir. "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. 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."
