Biotech Values

[DewDiligence]

ENTA starts/resumes two phase-1b HBV trials:

https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-Announces-Clinical-Trial-Progress-for-EDP-514-its-Lead-Core-Inhibitor-for-Hepatitis-B-Virus/default.aspx

Enanta Pharmaceuticals…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 [i.e. treatment-naïve] 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.

…The 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 subjects who will be randomized to receive one of three multiple ascending doses of EDP-514 or placebo.

The randomized, double-blind, placebo-controlled Phase 1b study in NUC-suppressed subjects with chronic HBV infection is Part 2 of a Phase 1a/1b study. Part 2 of the study 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 subjects who will be randomized to receive one of three multiple ascending doses of EDP-514 or placebo.

Data from both trials is expected in 1H21.