Feedback Supports Preclinical and Clinical Development Plan and Planned IND Filing for CRV431 for NASH
Edison, NJ (GLOBE NEWSWIRE) - 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.”
About ContraVir Pharmaceuticals
ContraVir is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. For more information, please visit www.contravir.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on ContraVir’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the design, progress and timing of preclinical and clinical studies, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir’s Form 10-K for the year ended December 31, 2018 and other periodic reports filed with the Securities and Exchange Commission.
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SOURCE: ContraVir Pharmaceuticals Inc.