Assembly Biosciences has dosed the first participant in a Phase 1b study of ABI-1179, an oral, long-acting herpes simplex virus (HSV) helicase-primase inhibitor. The study will evaluate the safety and antiviral activity of weekly doses of ABI-1179 in individuals with recurrent genital herpes over 29 days, measuring viral shedding, HSV-2 DNA levels, and lesion characteristics. This follows positive Phase 1a results demonstrating a pharmacokinetic profile supporting once-weekly dosing and potent antiviral activity.
This development is important because current treatments for recurrent genital herpes offer limited effectiveness in preventing outbreaks and viral transmission. ABI-1179 represents a potential new therapeutic approach with a novel mechanism of action—inhibiting the viral helicase-primase complex—which has previously demonstrated the potential for superior efficacy compared to existing nucleoside analog therapies. The unmet need for more effective and convenient treatments underscores the significance of this trial.
Assembly Bio is concurrently running Phase 1b studies for both ABI-1179 and another HSV candidate, ABI-5366, with similar study designs and overlapping sites. The company has expanded the ABI-1179 trial to US sites to maintain enrollment timelines. Interim data from both studies are expected in Fall 2025. Gilead Sciences holds an option to exclusively license both drug candidates after reviewing the Phase 1b data.
The progress of ABI-1179 into Phase 1b represents a critical step towards potentially bringing a new, long-acting therapy to patients with recurrent genital herpes. The upcoming interim data will be crucial in determining the future development and potential licensing of this promising drug candidate, which could significantly impact the treatment landscape for this common and often debilitating viral infection.
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.
