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Press Release

ContraVir Pharmaceuticals Announces Acceptance of Clinical Trial Application in the United Kingdom


Posted on: 06 Sep 17

EDISON, N.J., Sept. 06, 2017 (GLOBE NEWSWIRE) -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the Clinical Trial Application (CTA) for the formulation optimization clinical program for TXL™ has been approved in the United Kingdom by the Medicines & Healthcare Products Regulatory Agency (MHRA).

Earlier this year, ContraVir announced that it had completed a Phase 1, multiple dose study in healthy subjects and a Phase 2a, 28 day study which was a head-to-head comparison of TXL™ to Viread® in HBV-infected subjects. Having successfully achieved proof-of-concept with the first generation formulation of TXL™, ContraVir is developing a second-generation formulation of TXL™ to further optimize the pharmacological characteristics of its novel, liver-targeted tenofovir prodrug, Data from this program will drive the continued clinical development of TXL™, and support the goals of enhanced efficacy at lower doses, potentially delivering greater antiviral potency, while maintaining the low concentrations of circulating tenofovir in the blood necessary to minimize the risks of bone and kidney toxicity seen with Viread®.

ContraVir expects to dose its first patient in the UK before the end of this month. “We look forward to reporting on our progress, as our team is committed to establishing TXL™ as a potent and safe potential backbone therapy for a functional cure,” said James Sapirstein, Chief Executive Officer at ContraVir. “This is yet another great milestone achieved, as key European approval will permit accelerated optimization of our new formulation and further differentiation of TXL™ in the clinic.”

About TXL™

Tenofovir exalidex (TXL™) is a highly potent prodrug of the antiviral tenofovir.  Tenofovir is the active component of both Vemlidy® (tenofovir alafenamide) and Viread® (tenofovir disoproxil fumarate).TXL™’s novel liver-targeting prodrug structure results in decreased systemic circulating levels of tenofovir, thereby reducing the potential for renal and bone side effects. ContraVir has completed a Phase 2 trial of TXL™, in which HBV-infected subjects were administered doses up to 100 mg for 28 days and is now optimizing the formulation of TXL™ to further enhance drug bioavailability. To date, TXL™ has achieved clinical proof of concept for antiviral activity and displayed an excellent safety, tolerability, and pharmacokinetic profile. Based on the agent’s best-in-class potential, ContraVir believes TXL™ can become the cornerstone of a curative combination therapy for hepatitis B.

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™ currently in Phase 2, is designed to deliver high intrahepatic concentrations of TFV, while minimizing off-target side-effects caused by high levels of circulating TFV. CRV431, the other anti-HBV compound, is a next-generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against HBV. ContraVir is also developing Valnivudine™, an orally available nucleoside analogue prodrug; Valnivudine™ is currently in Phase 3 for the treatment of herpes zoster. In addition to direct antiviral activity, Phase 2 data suggest that Valnivudine™ has the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN). 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-K for the year ended June 30, 2016 and other periodic reports filed with the Securities and Exchange Commission. 

CONTACT: For further information, please contact: Sharen Pyatetskaya Director of Investor Relations sp@contravir.com; (732) 902-4028GlobeNewswire
globenewswire.com

Last updated on: 06/09/2017

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