Assembly Biosciences Doses First Participant in Phase 1a Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus

Core Insights - Assembly Biosciences has initiated a Phase 1a clinical trial for ABI-6250, an oral small molecule candidate targeting hepatitis delta virus (HDV) [1][2] - The trial aims to evaluate the safety, tolerability, and pharmacokinetics of ABI-6250 in healthy participants, with data expected in Q3 2025 [1][2] - ABI-6250 has the potential to be the first oral therapy for chronic HDV, a severe form of viral hepatitis with limited treatment options [4] Company Overview - Assembly Biosciences is focused on developing innovative therapeutics for serious viral diseases, including herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) [8] - The company is led by a team experienced in virologic drug development and aims to improve patient outcomes [8] Clinical Trial Details - The Phase 1a study will assess single and multiple ascending doses of ABI-6250, including safety, tolerability, pharmacokinetics, and serum bile acids as a biomarker for target engagement [2][6][7] - The trial will involve healthy participants randomized between ABI-6250 and placebo across multiple cohorts [6][7] - Results from this trial will inform dose selection for future clinical studies [7] Current Treatment Landscape - Currently, there is one approved therapy for chronic HDV infection in the European Union, which requires daily injections [3] - There are no approved therapies for chronic HDV infection in the United States, highlighting a significant unmet medical need [3]