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Enanta Pharmaceuticals Announces Clinical Trial Progress for EDP-514, its Lead Core Inhibitor for Hepatitis B Virus
Initiated Phase 1b Study Evaluating EDP-514 in Viremic HBV Patients; Preliminary Data Anticipated in 1H 2021 Resumed Phase 1b Study Assessing Safety and
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nInitiated Phase 1b Study Evaluating EDP-514 in Viremic HBV Patients; Preliminary Data Anticipated in 1H 2021\n\n\nResumed Phase 1b Study Assessing Safety and Antiviral Activity of EDP-514 in NUC-Suppressed HBV Patients; Topline Results Anticipated in 2Q 2021\n\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced advancements in its hepatitis B virus (HBV) program evaluating EDP-514 across different patient populations. Enanta initiated, as planned, a Phase 1b clinical trial in viremic HBV patients, and resumed its ongoing Phase 1b study in HBV patients treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients), which was previously paused due to the COVID-19 pandemic. EDP-514 is a novel class II HBV core inhibitor that has Fast Track Designation from the FDA.\n\n\n“HBV is a potentially life-threatening liver infection, affecting over 250 million people worldwide for which there is no functional cure. We are pleased to continue to advance our HBV program with two clinical studies evaluating EDP-514 in chronic HBV patients – one in viremic patients not currently on therapy and the second in patients with HBV infection that is NUC-suppressed,” said Jay R. Luly, President and Chief Executive Officer of Enanta Pharmaceuticals. “EDP-514, a novel core inhibitor of HBV replication, leverages our strength in compound optimization and targeted rational design, enabling potent anti-HBV activity at multiple steps in the HBV lifecycle. We are excited to further investigate EDP-514 in viremic HBV patients, and look forward to reporting preliminary safety and virologic data in the first half of 2021, while also completing our study in NUC-suppressed patients with topline data expected in the second quarter of 2021. As we look toward these catalysts, we are continuing to monitor any impact of the COVID-19 pandemic on our clinical progress.”\n\n\nThe randomized, double-blind, placebo-controlled Phase 1b study in viremic chronic HBV subjects not currently on therapy is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of orally administered EDP-514 over a 28-day period. The study is planned to enroll 24 subje...