EDISON, N.J., Oct. 17, 2016 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that following a positive recommendation from an independent Data Safety Monitoring Board (DSMB), the company has begun enrolling the next dosing group in its head-to-head Phase 2a dose-escalation study comparing the safety and efficacy of ContraVir's CMX157 to tenofovir disoproxil fumarate (TDF, marketed by Gilead Sciences as Viread®) in patients with chronic hepatitis B (HBV). ContraVir expects to complete the remaining two escalation cohorts and report top-line results by year-end 2016.
The DSMB conducted an independent review of the safety, tolerability and pharmacokinetic profile of CMX157 from the completed 5 mg, 10 mg and 25 mg dosing groups of ContraVir's ongoing, 28-day, Phase 2a study in HBV-infected patients. Based on CMX157's favorable safety and tolerability in this study as well as in a completed Phase 1b study in healthy volunteers, which dosed up to 100 mg of CMX157 per day, the DSMB approved proceeding to a higher dose in the ongoing Phase 2a dose escalation trial per study protocol.
"Coupled with our recent demonstration of clinical proof of concept for CMX157 in HBV patients, the DSMB's confirmation of CMX157's safety profile continues to build the case for this drug's potential as a cornerstone for combination therapy to cure HBV," said James Sapirstein, CEO of ContraVir. "We look forward to reporting final Phase 2a data by year end, and continue to believe that CMX157 has the ideal attributes needed for use as a component of a future combination drug strategy where drug-drug interactions put high demands on safety."
ContraVir recently announced positive interim data demonstrating strong antiviral activity and favorable safety and pharmacokinetics for CMX157. Notably, a 25 mg dose of CMX157 achieved comparable HBV viral load reduction to the standard 300 mg dose of Viread®, but with significantly reduced systemic levels of active tenofovir. Results from the completed Phase 1b and ongoing Phase 2a clinical trials suggest that CMX157 is a highly potent HBV antiviral that may mitigate the risk of kidney and bone toxicities that are associated with Viread®.
CMX157 Phase 2 Clinical Trial DesignThe Phase 2a multiple ascending dose clinical trial, which is designed to enroll 60 treatment-naïve patients with chronic HBV infection, compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead's Viread®). The sequential dose escalation format consists of 10 patients per cohort receiving four weeks of a once-daily dose of 5, 10, 25, 50 and 100 mg, respectively, of CMX157, plus two patients per cohort receiving 300 mg of TDF, the standard therapeutic dose of Viread®.
About CMX157CMX157 is a highly potent analog of the successful antiviral drug tenofovir. Its novel liver-targeting structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. CMX157 previously completed a Phase 1b dose escalation clinical study conducted in healthy volunteers, in which participants were treated at doses up to 100 mg per day for 14 days, displaying an excellent safety, tolerability, and drug distribution profile. Based on CMX157's best-in-class potential, ContraVir believes CMX157 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: CMX157, a highly potent analog of the successful antiviral drug tenofovir currently in a Phase 2a clinical trial in HBV patients; and CRV431, a next generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against HBV. ContraVir is also developing FV-100, an orally available nucleoside analogue prodrug for the treatment of herpes zoster, or shingles, in a Phase 3 clinical trial. In addition to direct antiviral activity, FV-100 previously demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. 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.
For further information, please contact:
Sharen Pyatetskaya Director of Investor [email protected]; (732) 902-4028
Tiberend Strategic Advisors, Inc. Joshua Drumm, Ph.D. (investors) [email protected]; (212) 375-2664
Claire LaCagnina (media)[email protected]; (212) 375-2686
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The DSMB conducted an independent review of the safety, tolerability and pharmacokinetic profile of CMX157 from the completed 5 mg, 10 mg and 25 mg dosing groups of ContraVir's ongoing, 28-day, Phase 2a study in HBV-infected patients. Based on CMX157's favorable safety and tolerability in this study as well as in a completed Phase 1b study in healthy volunteers, which dosed up to 100 mg of CMX157 per day, the DSMB approved proceeding to a higher dose in the ongoing Phase 2a dose escalation trial per study protocol.
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"Coupled with our recent demonstration of clinical proof of concept for CMX157 in HBV patients, the DSMB's confirmation of CMX157's safety profile continues to build the case for this drug's potential as a cornerstone for combination therapy to cure HBV," said James Sapirstein, CEO of ContraVir. "We look forward to reporting final Phase 2a data by year end, and continue to believe that CMX157 has the ideal attributes needed for use as a component of a future combination drug strategy where drug-drug interactions put high demands on safety."
ContraVir recently announced positive interim data demonstrating strong antiviral activity and favorable safety and pharmacokinetics for CMX157. Notably, a 25 mg dose of CMX157 achieved comparable HBV viral load reduction to the standard 300 mg dose of Viread®, but with significantly reduced systemic levels of active tenofovir. Results from the completed Phase 1b and ongoing Phase 2a clinical trials suggest that CMX157 is a highly potent HBV antiviral that may mitigate the risk of kidney and bone toxicities that are associated with Viread®.
CMX157 Phase 2 Clinical Trial DesignThe Phase 2a multiple ascending dose clinical trial, which is designed to enroll 60 treatment-naïve patients with chronic HBV infection, compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead's Viread®). The sequential dose escalation format consists of 10 patients per cohort receiving four weeks of a once-daily dose of 5, 10, 25, 50 and 100 mg, respectively, of CMX157, plus two patients per cohort receiving 300 mg of TDF, the standard therapeutic dose of Viread®.
About CMX157CMX157 is a highly potent analog of the successful antiviral drug tenofovir. Its novel liver-targeting structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. CMX157 previously completed a Phase 1b dose escalation clinical study conducted in healthy volunteers, in which participants were treated at doses up to 100 mg per day for 14 days, displaying an excellent safety, tolerability, and drug distribution profile. Based on CMX157's best-in-class potential, ContraVir believes CMX157 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: CMX157, a highly potent analog of the successful antiviral drug tenofovir currently in a Phase 2a clinical trial in HBV patients; and CRV431, a next generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against HBV. ContraVir is also developing FV-100, an orally available nucleoside analogue prodrug for the treatment of herpes zoster, or shingles, in a Phase 3 clinical trial. In addition to direct antiviral activity, FV-100 previously demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. 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.
For further information, please contact:
Sharen Pyatetskaya Director of Investor [email protected]; (732) 902-4028
Tiberend Strategic Advisors, Inc. Joshua Drumm, Ph.D. (investors) [email protected]; (212) 375-2664
Claire LaCagnina (media)[email protected]; (212) 375-2686
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SOURCE ContraVir Pharmaceuticals, Inc.
