Assembly Biosciences has dosed the first participant in a Phase 1a clinical trial for ABI-6250, an oral HDV entry inhibitor. The trial will assess the safety, tolerability, pharmacokinetics, and serum bile acid levels (a biomarker for target engagement) of ABI-6250 in healthy individuals. Data from this trial is anticipated in Q3 2025.
This clinical trial initiation is a crucial step forward in addressing the unmet need for effective HDV treatments. Currently, only one therapy, requiring daily injections, is approved for chronic HDV (cHDV) in the European Union and none in the United States. An easily administered oral therapy like ABI-6250 could significantly improve patient compliance and quality of life, potentially transforming the cHDV treatment landscape. Given the severity of cHDV, with a high rate of cirrhosis progression, a new therapeutic option offers significant hope.
The Phase 1a trial (ABI-6250-101) is a randomized, placebo-controlled study evaluating single and multiple ascending doses of ABI-6250 in healthy participants. The multiple-dose cohorts will involve repeat dosing over 10 days. Preclinical studies have shown promising results, including low nanomolar potency across multiple HDV genotypes, selectivity for its target (NTCP), and a pharmacokinetic profile suggesting the feasibility of once-daily oral dosing. The trial will help determine the appropriate dose for future clinical studies.
The initiation of this Phase 1a trial represents a significant milestone for Assembly Biosciences and for the development of a potentially transformative HDV treatment. Positive results from this trial could pave the way for further clinical development and ultimately offer a much-needed oral therapeutic option for patients with cHDV. The data expected in Q3 2025 will be eagerly awaited by the medical community and patients alike.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
