ContraVir Pharmaceuticals Reports Progress in Phase 1/2A Trial of CRV431
“Initial data from the first dosing cohort in Part 1 of the Phase 1/2A trial of CRV431 was encouraging, with results indicating the drug is safe and yields a pharmacokinetic profile suggesting favorable oral bioavailability,” said
The Phase 1/2A trial of CRV431 is designed as a randomized, partially-blinded, placebo-controlled study consisting of three parts. Part 1 of the study is intended to assess the safety, tolerability, and PK profile of CRV431 when administrated as a single oral dose in healthy volunteers. Part 2 of the clinical trial will consist of a single dose of CRV431, in combination with standard-of-care tenofovir disoproxil fumarate (marketed by Gilead as Viread®,TDF) to determine the safety, tolerability and PK. Part 3 of the study will assess the safety, tolerability, PK and antiviral efficacy of CRV431 in stable HBV patients currently receiving a daily regimen of TDF.
CRV431 is a non-immunosuppressive analog of cyclosporine A (CsA) whose primary biochemical action is inhibition of cyclophilin isomerase activity, playing a key role in protein folding. Other viruses such as HIV-1 and HCV, similarly use cyclophilin for their replication. In pre-clinical studies, CRV431 has shown potential in experimental models to complement current hepatitis B treatments by reducing multiple markers of infection including HBV DNA, HBsAg, HBeAg, and HBV uptake by cells. Studies have also demonstrated that CRV431 reduces the progression of fibrosis in an animal model and also reduces both the number and size of liver tumors in a hepatocellular carcinoma (HCC) model. CRV431 is currently the subject of a Phase 1 clinical trial testing clinical safety and efficacy in healthy volunteers and HBV patients.
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with a specific focus on developing a potentially curative oral therapy for hepatitis B virus (HBV). The company is developing two novel anti-HBV compounds with complementary mechanisms of action. TXL™, a direct acting antiviral (DAA) nucleotide analog lipid prodrug of tenofovir (TFV), is designed to deliver higher hepatic intracellular concentrations of the active tenofovir species (tenofovir diphosphate) while reducing concentrations of tenofovir outside the liver, causing fewer off-target toxicities and side-effects. CRV431, the other anti-HBV compound, is a host-targeting antiviral (HTA) next-generation cyclophilin inhibitor with a novel chemical structure that optimizes the selective index against HBV. In vitro and in vivo studies have thus far demonstrated that CRV431 reduces HBV DNA and other viral proteins, including surface antigen (HBsAg), while offering additional benefits to mitigate liver 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
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Source: ContraVir Pharmaceuticals Inc.