August 6, 2025 — Assembly Biosciences, Inc. (Nasdaq: ASMB) announced interim data from its Phase 1a clinical trial of ABI-6250, an oral hepatitis delta virus (HDV) entry inhibitor.
Data showed ABI-6250 has a four-day half-life, supporting daily oral dosing and dose-dependent elevations in a biomarker for target engagement. Further assessment will be done alongside Phase 2 preparation.
The study, ABI-6250-101, is a randomized, blinded, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of ABI-6250 in healthy participants.
A grade 2 alanine transaminase (ALT) elevation was observed in the highest single-dose cohort, with grade 1 elevations seen at a low frequency in other cohorts. All were self-limited and without liver injury markers.
“We are encouraged by the observed half-life supportive of once-daily oral dosing and bile acid elevations indicative of NTCP target engagement,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio.
ABI-6250 is an investigational product and its safety and efficacy have not been established.
Investor Contact:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
Media Contact:
Alyssa Kuciunas
(331) 481-3751
ASMBMedia@sambrown.com
Source: Assembly Biosciences
