Biotech Values

[DewDiligence]

ENTA starts phase-1 of EDP-514 for treatment of HBV:

https://www.enanta.com/investors/news-releases/press-release/2019/Enanta-Pharmaceuticals-Initiates-Phase-1-Clinical-Study-of-EDP-514-its-Lead-Core-Inhibitor-for-the-Treatment-of-Hepatitis-B-Virus-HBV/default.aspx

The randomized, double-blind, placebo-controlled Phase 1a/b study is designed to evaluate first the safety, tolerability and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-514 in healthy subjects (Part 1), and then the antiviral activity of EDP-514 in nucleos(t)ide-reverse-transcriptase (NUC)-suppressed patients with chronic HBV infection (Part 2).

The study plans to enroll approximately 98 subjects and to evaluate up to 6 dose cohorts, with EDP-514 administered orally, once daily.

EDP-514 is an HBV core inhibitor (a/k/a capsid-assembly modulator or CpAM); ENTA’s main competition in this arena is ASMB (#msg-148672065, #msg-148259315).

ENTA now has drug candidates in the clinic for NASH/PBC (EDP-305); RSV (EDP-938); and HBV (EDP-514). The R&D costs for these programs are easily covered by ENTA’s royalty income from Mavyret, the world’s largest-selling drug for HCV.