IND positions NASH as a second indication for CRV431, in addition to HBV
EDISON, N.J., June 27, 2019 (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 the filing of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for CRV431 for the treatment of NASH.
ContraVir’s proposed IND opening study is entitled, “An Open-Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431.” The study will enroll 24 patients, consisting of eight with mild, eight with moderate, and eight with severe hepatic impairment, based on Child-Pugh scores. Up to an additional 24 healthy subjects will serve as the control group. The objective of the IND opening study and proposed clinical development program is to characterize the role of CRV431 monotherapy as anti-fibrotic treatment in NASH patients.
“Our team has worked diligently to assemble this IND submission,” commented Dr. Robert Foster, ContraVir’s CEO. “We hope to receive confirmation that our submission has been accepted by the FDA, Center for Drug Evaluation and Research, in due course. 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.”
This application, number IND142904, follows an earlier IND that was approved for the hepatitis B virus (“HBV”) indication. Under the previous IND for HBV, ContraVir has completed a phase 1 single ascending dose study in healthy human subjects, demonstrating good safety and tolerability and defining the pharmacokinetics of CRV431. A second clinical study of CRV431 examined the pharmacokinetics of CRV431 when co-administered with tenofovir disoproxil fumarate (“TDF”). The Company expects to initiate a third clinical study of CRV431, in the near future, to determine safety, tolerability, and pharmacokinetics after repeated, escalating oral dosing in HBV patients over a period of 28 days.
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, 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.
For further information, please contact:
ContraVir Investor Relations