Business
Enanta Pharmaceuticals Reports Positive Final Data from its Phase 1b Studies of EDP-514, a Novel Hepatitis B Virus Core Inhibitor
EDP-514 is Safe and Well-Tolerated up to 800 mg Robust Antiviral Activity Demonstrated in Chronic Hepatitis B Virus Patients at All Doses WATERTOWN,
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\nEDP-514 is Safe and Well-Tolerated up to 800 mg\n\nRobust Antiviral Activity Demonstrated in Chronic Hepatitis B Virus Patients at All Doses\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 final Phase 1b data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, in conjunction with two posters presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).\n\n“We are excited to present final data for EDP-514 from our Phase 1b studies in viremic and NUC-suppressed chronic HBV patients, giving us continued confidence in EDP-514 as a potential treatment for HBV,” said Jay R. Luly, PhD, President and Chief Executive Officer of Enanta Pharmaceuticals. “At 800 mg, EDP-514 continues to demonstrate that it is safe and well-tolerated up to 28 days when dosed alone or in combination with NUC, as shown in the NUC-suppressed patients. Importantly, EDP-514 has robust antiviral activity across all dose groups, as best illustrated in the viremic patients where up to a 3.5 log decline in HBV DNA was observed. These data are supportive of a once-daily oral dosing regimen that could provide a foundation for a combination therapy approach to achieve functional cures for chronic HBV patients.”\n\n822: “EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor: Results of a 28-day Phase 1b Study in NUC-Suppressed CHB Patients”\nJordan J. Feld, MD, MPH, Toronto Centre for Liver Disease, University Health Network, Toronto, Canada\n\nThe poster highlights data from Part 2 of a Phase 1a/1b randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics and antiviral activity of three doses of EDP-514 in 24 NUC-suppressed chronic HBV patients who were either HBeAg-positive or HBeAg-negative. Patients were randomized to receive 200 mg (n=6), 400 mg (n=6), 800 mg (n=6) of EDP-514 or placebo (n=6) daily for 28 days.\n\nOverall, EDP-514 was generally safe and well-tolerated at 200 mg, 400 mg, and 800 mg doses for 28 days. EDP-514 was rapidly absorbed and its exposure increased with increasing multiple doses. EDP-514 exhibited pharmacokinetics suitable ...