EDISON, NJ, USA I March 3, 2016 I ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, reported today a positive outcome from an important drug-drug interaction study regarding the Company’s novel antiviral drug candidate FV-100, which is currently in Phase 3 clinical development to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
The drug-drug interaction study examined oral co-administration of FV-100 with ritonavir, a known inhibitor of the key drug metabolism enzyme CYP3A and the P-glycoprotein (P-gp) drug transporter, both of which are involved in a large number of adverse drug-drug interactions. FV-100 was safe and well tolerated in this study. Importantly, the results showed that inhibition of CYP3A or P-gp by ritonavir or any other drugs that inhibit CYP3A or P-gp, is unlikely to elicit a clinically significant drug-drug interaction that could compromise the safety or efficacy of FV-100.
James Sapirstein, Chief Executive Officer of ContraVir, said “Confirming the safety of FV-100 in this drug-drug interaction study and eliminating the potential liability of CYP3A/P-gp inhibition adversely affecting the pharmacokinetic profile of FV-100 is significant given the advanced age of the shingles population and the multiple medications these patients are likely to be taking. We continue to enroll patients into our pivotal study of FV-100 with added confidence that it has the potential to be a safe and differentiated antiviral product with the unique potential to prevent PHN pain.”
About FV-100
FV-100 is a fast acting, low dose, once-daily oral antiviral agent being developed for the treatment of herpes zoster, or shingles, which is an infection caused by the reactivation of varicella zoster virus. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.
About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir’s lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus. CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.
SOURCE: ContraVir Pharmaceuticals
Post Views: 72
EDISON, NJ, USA I March 3, 2016 I ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, reported today a positive outcome from an important drug-drug interaction study regarding the Company’s novel antiviral drug candidate FV-100, which is currently in Phase 3 clinical development to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
The drug-drug interaction study examined oral co-administration of FV-100 with ritonavir, a known inhibitor of the key drug metabolism enzyme CYP3A and the P-glycoprotein (P-gp) drug transporter, both of which are involved in a large number of adverse drug-drug interactions. FV-100 was safe and well tolerated in this study. Importantly, the results showed that inhibition of CYP3A or P-gp by ritonavir or any other drugs that inhibit CYP3A or P-gp, is unlikely to elicit a clinically significant drug-drug interaction that could compromise the safety or efficacy of FV-100.
James Sapirstein, Chief Executive Officer of ContraVir, said “Confirming the safety of FV-100 in this drug-drug interaction study and eliminating the potential liability of CYP3A/P-gp inhibition adversely affecting the pharmacokinetic profile of FV-100 is significant given the advanced age of the shingles population and the multiple medications these patients are likely to be taking. We continue to enroll patients into our pivotal study of FV-100 with added confidence that it has the potential to be a safe and differentiated antiviral product with the unique potential to prevent PHN pain.”
About FV-100
FV-100 is a fast acting, low dose, once-daily oral antiviral agent being developed for the treatment of herpes zoster, or shingles, which is an infection caused by the reactivation of varicella zoster virus. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.
About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir’s lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus. CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.
SOURCE: ContraVir Pharmaceuticals
Post Views: 72
