Core Insights - Assembly Biosciences, Inc. announced positive interim Phase 1a results for ABI-1179, a long-acting helicase-primase inhibitor targeting recurrent genital herpes [1][4] - The drug demonstrated a mean half-life of approximately four days, supporting a once-weekly oral dosing regimen, and was well-tolerated with a favorable safety profile [2][7][9] - The company plans to advance ABI-1179 into Phase 1b studies concurrently with ABI-5366, another investigational candidate, with interim data expected in fall 2025 [3][10] Study Overview - The Phase 1a study (ABI-1179-101) is a randomized, blinded, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of ABI-1179 in healthy participants [5] - Dosing has been completed for three cohorts (50 mg, 100 mg, and 300 mg), with a randomized allocation of 6:2 between ABI-1179 and placebo [5] Safety and Efficacy - ABI-1179 was well-tolerated across all evaluated doses, with mild treatment-emergent adverse events and no serious adverse events reported [9] - A self-limited grade 2 alanine transaminase elevation was noted in the highest dose cohort, but no significant ECG abnormalities or severe laboratory issues were observed [9] Future Plans - The Phase 1b study will evaluate multiple ascending doses of ABI-1179 in participants with recurrent genital herpes, focusing on safety, tolerability, pharmacokinetics, and antiviral activity [10][11] - The study will assess changes in viral parameters and clinical outcomes, including lesion recurrence rates [11] Industry Context - Recurrent genital herpes affects millions, with current treatments being only partially effective; no new drugs have been approved for over 25 years [13] - The helicase-primase inhibition mechanism has shown potential for superior efficacy compared to existing nucleoside analogs [14]
Assembly Biosciences Reports Positive Interim Phase 1a Results from Clinical Trial Evaluating Long-Acting Helicase-Primase Inhibitor ABI-1179 in Development for Recurrent Genital Herpes