Assembly Biosciences, Inc., a biotechnology company specializing in novel therapies for serious viral diseases, has announced the commencement of dosing for the Phase 1b trial of ABI-4334. This compound, a next-generation capsid assembly modulator (CAM), is aimed at treating chronic hepatitis B virus (HBV) infection.

Chronic HBV infection is a significant contributor to chronic liver disease and liver transplants worldwide, with over one million deaths attributed to HBV-related causes in 2022 by the World Health Organization. Current treatments, which often require lifelong administration, only suppress the virus and have low cure rates. CAMs such as ABI-4334 directly combat HBV by inhibiting HBV DNA replication and preventing the formation of new cccDNA, the viral reservoir. ABI-4334 is specifically designed for high potency against both mechanisms.

ABI-4334 demonstrated a favorable safety and pharmacokinetic profile in healthy participants during a Phase 1a study, where once-daily oral dosing achieved promising results. The compound showed potent activity in vitro, with significant impact on HBV DNA replication, cccDNA formation, and HBV DNA integration at single-digit nanomolar levels. The ongoing Phase 1b trial aims to evaluate ABI-4334's safety, pharmacokinetics, and antiviral activity over a 28-day treatment period in individuals with chronic HBV infection.

Assembly Bio, expressed optimism about ABI-4334's potential to deliver best-in-class antiviral efficacy. He highlighted the importance of the 28-day placebo-controlled study in assessing ABI-4334's impact on HBV DNA levels and refining safety data. Interim results from this study are expected later in the year.

ABI-4334-102 is a Phase 1b study designed as a randomized, blinded, placebo-controlled dose-ranging trial to evaluate ABI-4334 in participants with chronic HBV infection. The study will enroll up to 50 subjects across five sequential cohorts, with participants randomized 8:2 between ABI-4334 and placebo. The trial's objectives include assessing safety, pharmacokinetics, and antiviral effects, with results informing future dose selection.

 

Source: globenewswire.com

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