Benzinga | May 6, 2021 04:14PM EDT

Enanta Pharmaceuticals Reports Positive Data from Part 2 of its Phase 1b Study of EDP-514 in Chronic Hepatitis B Virus Patients on Treatment with a Nucleoside Reverse Transcriptase Inhibitor

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive data from the first two dose cohorts of Part 2 of its Phase 1b study of EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, the Company's novel class II oral HBV core inhibitor, was safe and well-tolerated, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in a mean reduction in HBV RNA of 1 log.

"These positive clinical trial results from the 200 mg and 400 mg cohorts are very encouraging and support the continued advancement of EDP-514 as a potential treatment for HBV," said Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. "We are particularly encouraged by the emerging safety and tolerability profile of EDP-514 in combination with NUC treatment, which could provide a foundation for a combination therapy approach to achieve functional cures in patients with chronic HBV infection. We look forward to progressing our clinical program for EDP-514 and completing the 800 mg cohort, as well as reporting data on our ongoing Phase 1b study in viremic patients later this quarter, which will provide key information about the impact of EDP-514 on HBV DNA levels.

The randomized, double-blind, placebo-controlled Phase 1b study is Part 2 of a Phase 1a/1b study assessing the safety, tolerability, PK 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. The 800 mg cohort is ongoing and final study results will be presented at a future scientific conference.