ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV) jumped over 21% Friday after the FDA responded to the company's IND package and concurred with the company's proposed plan for further preclinical studies to support the development of CRV431 in NASH.
The biopharmaceutical company, based in Edison, New Jersey, focuses 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.
CEO Robert Foster said, "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."
The company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH.
Shares sank Monday, however, by 43 cents, or 8.3% to $4.77
