EDISON, N.J., June 21, 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), announced today the company has chosen an optimized formulation of tenofovir exalidex (TXL™) and is ready to initiate dosing HBV patients in a dose-range finding study with the optimized formulation.
TXL™ has been designed to target the liver to deliver the active drug to the reservoir where the hepatitis B virus resides. TXL™ displayed a favorable safety and tolerability profile in a completed Phase 2a study of HBV patients at doses up to 100 mg. The Phase 2a study confirmed that TXL™ administration resulted in lower circulating levels of tenofovir (TFV), compared with levels observed after administration of Viread® (tenofovir disoproxil fumarate, TDF). Higher circulating levels of TFV, associated with TDF, have previously been shown to cause kidney and bone toxicities. Importantly, TXL™ dosing reduced viremia (HBV DNA) to the same extent as TDF, while minimizing TFV levels associated with these well-known toxicities.
ContraVir undertook studies to optimize the formulation of TXL™ to allow for more efficient, predictable, and precise delivery to the target organ (i.e., liver), thereby potentially reducing drug burden while maintaining consistent efficacy. The optimization of TXL™ was additionally designed to diminish the impact of physiological variables allowing for more consistent delivery of the prodrug to the site of action. Consistent and predictable target organ delivery is necessary, especially as curative combination regimens are developed for a functional cure.
“The ultimate goal in enhancing drug formulation is to offer a potential therapeutic benefit that could allow for more precise and predictive dosing while remaining safe and well tolerated,” said James Sapirstein, Chief Executive Officer of ContraVir. “With future fixed-dose combinations in mind and positioning TXL™ as part of the backbone therapy, our goal was to further enhance the delivery of TXL™ to the liver, and ultimately achieve better results when testing TXL™ in combination with other agents active against HBV, including CRV431, our second investigational compound. We believe that with the current findings of TXL™ showing no food effect and no need for dosing adjustment in patients with decreased renal function, TXL™ has the potential to be the tenofovir of choice.”
The objective of the next clinical trial with TXL™ will be to characterize the pharmacokinetic profile of the new formulation in HBV patients, and to select the target dose to be advanced into a Phase 3 registration clinical development program.
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 therapy for hepatitis B virus (HBV). The company is developing two novel anti-HBV compounds with complementary mechanisms of action. TXL™, a nucleoside 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 next-generation cyclophilin inhibitor with a novel structure that increases its potency and 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). For more information 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-KT for the year ended December 31, 2017 and other periodic reports filed with the Securities and Exchange Commission.
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