Enanta announces the official launch of Phase Ia/b clinical study on EDP-514 for HBV infection
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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Recently, EnantaPharmaceutical(http://Company(http://announced the launch of Phase Ia/b clinical study on the treatment of HBV infection with lead core inhibitor EDP-514 (Part 1)EDP-514
EDP-514 is a new type of HBV core inhibitor and is a leadingdrug(http://of Enanta.comCore inhibitors, also known as shell assembly regulators or core protein deconsodants, are a new class of replication inhibitors that have been shown to work at multiple steps in the HBV life cyclePreclinical data indicate that EDP-514 is an effective HBV replication inhibitor that is given to EDP-514 early in HBV infection to prevent the formation of new CCCDNA (de novo formation) in primary liver cellsIn vitro data also show that EDP-514 is generic, and that the combination of the drug with nucleoside retrovirus inhibitors (NRTIs, currentHBV antiviral therapy) or Class I core inhibitors can increase synergistic antiviral effectsIn the inviva model, EDP-514 showed strong efficacy in PXB mice infected with HBV, reducing the viral load by more than 4-logThe study Phase Ia/b Clinical Study is a randomized, double-blind, placebo-controlled Phase Ia/b study, the first part (Part 1) in the Health (http:// the subjects to evaluate single incremental dose (SAD) and multiple incremental dose (MAD) ) The safety, tolerability and pharmacokinetics (PK), Part II (Part 2) assessed the antiviral activity of EDP-514 in patients with chronic HBV inhibited by nucleoside reverse transcriptase (NUC) The study enrolled about 98 subjects and evaluated up to six dose queues, with EDP-514 being taken orally once a day After completing the SAD and MAD parts of healthy subjects, the study will assess the safety, PK and EDP-514 antiviral data of people with chronic HBV
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