EDISON, N.J., Oct. 30, 2018 (GLOBE NEWSWIRE) — ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (“HBV”), today announced that it has completed dosing of the last cohort of healthy subjects for its CRV431 drug-drug interaction (“DDI”) study. The single-dose crossover study evaluated subjects co-treated with Viread® (tenofovir disoproxil fumarate) (“TDF”), an approved treatment for chronic HBV infection. The DDI study is the second stage of CRV431’s streamlined early clinical program, which is agreed upon with the U.S. Food and Drug Administration (“FDA”).
“This DDI study will ensure that CRV431 can be safely combined with other drugs HBV patients are likely taking, particularly other antivirals,” said Dr. Robert Foster, Chief Executive Officer of ContraVir. “We are looking forward to generating favorable results, which would enable us to proceed to the final stage of our early clinical program for CRV431, and ultimately a Phase 2 clinical study.”
The DDI study follows the completion of the first stage of the program, announced on September 18, 2018, where CRV431 met the primary endpoints of safety and tolerability in a single ascending dose (“SAD”) study of healthy volunteers. The DDI study consists of three cohorts of the same 18 healthy volunteers. The first cohort of subjects received a single oral dose of CRV431 based on the selected dose (“SD”) from the SAD, followed by a 20-day pharmacokinetic (“PK”) study and washout period. The second cohort received 300mg of TDF followed by a six-day PK study and washout period. The Company has now completed dosing of the final cohort, where patients received both the SD of CRV431 and 300mg of TDF. The patients will now undergo a final PK study and observation period lasting 20 days, subject to availability of PK results. ContraVir expects to report results of the DDI study prior to the end of 2018.
With an FDA agreement of an accelerated clinical program for CR431, ContraVir plans to bridge from the DDI study into a multi-dose 28-day pilot in HBV patients, which will assess the safety, tolerability, PK, and preliminary signals for antiviral efficacy, as well as identify clinically-relevant biomarkers of CRV431 with 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, HBx, 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.
About ContraVir Pharmaceuticals
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 such as reducing liver fibrosis and hepatocellular carcinoma tumor burden. 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 30, 2017 and other periodic reports filed with the Securities and Exchange Commission.