ContraVir to Advance Second-Generation Formulation of Tenofovir Exalidex (TXL™) for Treatment of Hepatitis B Virus (HBV)
Subsequent to the DSMB’s clearance in
“Having established proof-of-principle with our first-generation formulation, we are excited to move forward with a second-generation formulation of TXL™, one that potentially delivers greater antiviral potency per dose,” said
“While the advancement of a new formulation may appear to be a significant shift in our clinical development program, such a change in course is not uncommon in the biopharmaceutical industry, in which the emergence of an improved formulation of a drug candidate often represents a clear streamlined path forward for a company dedicated to improving patient care,” commented
Tenofovir exalidex (TXL™) is a highly potent prodrug of the successful antiviral drug tenofovir. Its novel liver-targeting structure results in decreased systemic circulating levels of tenofovir, thereby reducing the potential for renal and bone side effects. ContraVir previously completed a Phase 1b dose-escalation trial of TXL™ in healthy volunteers, in which participants were treated at doses up to 100 mg per day for 14 days; in this trial, TXL™ displayed an excellent safety, tolerability, and drug distribution 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.
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. One compound, TXL™ is a, liver-targeted, lipid prodrug of the antiviral tenofovir which is the active drug in Velmidy® (tenofovir alafenamide) and, Viread® (tenofovir disoproxil fumerate) and is currently in Phase 2a of development. TXL™ has demonstrated the potential for low, once-daily dosing with a low systemic tenofovir exposure, thereby potentially reducing renal and bone side effects. 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.
TXL™ is a trademark of
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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Sharen PyatetskayaDirector of Investor Relations firstname.lastname@example.org; (732) 902-4028