WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has initiated a proof of concept study (POC) and has begun dosing with EDP-494, a potent, pan-genotypic cyclophilin inhibitor to treat patients with genotype 1 (GT1) or genotype 3 (GT3) chronic hepatitis C virus.
“This host-targeted approach may prove valuable not only in the toughest to treat patients with DAA resistance, but also in the general HCV patient population, given its pangenotypic mechanism of action and high barrier to resistance.”
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The double-blind, randomized POC portion of this ongoing phase 1 study will assess the safety, pharmacokinetics and anti-viral activity of two planned different doses of EDP-494 in treatment-naïve HCV patients dosed orally, once daily for 14 days. Safety and pharmacokinetics of single and multiple ascending doses of once daily, orally administered EDP-494 have been established in healthy volunteers and these data support the testing of EDP-494 in a proof-of-concept study in HCV patients.
EDP-494, a Cyclophilin Inhibitor for HCV Infection
Due to resistance arising with direct-acting antiviral HCV therapies currently on the market, Enanta has developed an alternative treatment approach to HCV that targets the human host protein cyclophilin, which is essential for replication of HCV. Since cyclophilin inhibitors act as host-targeted antivirals, the viral mutation resistance that arises from direct-acting antiviral (DAA) treatments would not be expected for this mechanism, and thus cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
“As the number of patients treated with the current HCV DAA regimens on the market rapidly increases, the treatment failure population will become an important unmet medical need in patients with hepatitis C and may require new mechanisms of therapy such as cyclophilin inhibition,” commented Professor Edward J. Gane, MD, Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital and chief investigator of the EDP-494 study. “This host-targeted approach may prove valuable not only in the toughest to treat patients with DAA resistance, but also in the general HCV patient population, given its pangenotypic mechanism of action and high barrier to resistance.”
Data presented at the International Liver Congress™ 1 in Barcelona in April, 2016 demonstrated that EDP-494 in replicon assays is a potent inhibitor of HCV replication and has shown no loss of potency against all major NS5A RAVs, NS5B RAVs (both Nucleotide and non-Nucleotide) as well as NS3 protease inhibitor RAVs.
Following the completion of the phase 1 study, Enanta plans to develop EDP-494 in combination with one or more DAAs for the treatment of any emerging HCV resistance to currently marketed therapies or any other therapies in development that use DAAs. Enanta anticipates that a DAA-cyclophilin inhibitor combination could provide one of the highest barrier to resistance combination treatments for HCV.
About EDP-494
EDP-494 is a cyclophilin inhibitor that targets the human host protein, cyclophilin, which is essential for replication of chronic hepatitis C virus (HCV). Host-targeted antivirals (HTAs) such as cyclophilin inhibitors are not affected by changes in the virus and, therefore, use of this class of inhibitor may provide a unique solution for a subset of hard-to-treat HCV patients. Enanta has demonstrated in replicon assays that EDP-494 is a potent inhibitor of HCV. A phase 1 clinical study in HCV patients is currently underway.
“This host-targeted approach may prove valuable not only in the toughest to treat patients with DAA resistance, but also in the general HCV patient population, given its pangenotypic mechanism of action and high barrier to resistance.”
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The double-blind, randomized POC portion of this ongoing phase 1 study will assess the safety, pharmacokinetics and anti-viral activity of two planned different doses of EDP-494 in treatment-naïve HCV patients dosed orally, once daily for 14 days. Safety and pharmacokinetics of single and multiple ascending doses of once daily, orally administered EDP-494 have been established in healthy volunteers and these data support the testing of EDP-494 in a proof-of-concept study in HCV patients.
EDP-494, a Cyclophilin Inhibitor for HCV Infection
Due to resistance arising with direct-acting antiviral HCV therapies currently on the market, Enanta has developed an alternative treatment approach to HCV that targets the human host protein cyclophilin, which is essential for replication of HCV. Since cyclophilin inhibitors act as host-targeted antivirals, the viral mutation resistance that arises from direct-acting antiviral (DAA) treatments would not be expected for this mechanism, and thus cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
“As the number of patients treated with the current HCV DAA regimens on the market rapidly increases, the treatment failure population will become an important unmet medical need in patients with hepatitis C and may require new mechanisms of therapy such as cyclophilin inhibition,” commented Professor Edward J. Gane, MD, Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital and chief investigator of the EDP-494 study. “This host-targeted approach may prove valuable not only in the toughest to treat patients with DAA resistance, but also in the general HCV patient population, given its pangenotypic mechanism of action and high barrier to resistance.”
Data presented at the International Liver Congress™ 1 in Barcelona in April, 2016 demonstrated that EDP-494 in replicon assays is a potent inhibitor of HCV replication and has shown no loss of potency against all major NS5A RAVs, NS5B RAVs (both Nucleotide and non-Nucleotide) as well as NS3 protease inhibitor RAVs.
Following the completion of the phase 1 study, Enanta plans to develop EDP-494 in combination with one or more DAAs for the treatment of any emerging HCV resistance to currently marketed therapies or any other therapies in development that use DAAs. Enanta anticipates that a DAA-cyclophilin inhibitor combination could provide one of the highest barrier to resistance combination treatments for HCV.
About EDP-494
EDP-494 is a cyclophilin inhibitor that targets the human host protein, cyclophilin, which is essential for replication of chronic hepatitis C virus (HCV). Host-targeted antivirals (HTAs) such as cyclophilin inhibitors are not affected by changes in the virus and, therefore, use of this class of inhibitor may provide a unique solution for a subset of hard-to-treat HCV patients. Enanta has demonstrated in replicon assays that EDP-494 is a potent inhibitor of HCV. A phase 1 clinical study in HCV patients is currently underway.
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