Assembly Biosciences announced that the first participant has been dosed in the Phase 1b portion of the Phase 1a/b study of its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-1179. This Phase 1b study will evaluate the safety and antiviral activity of weekly oral doses of ABI-1179 over a 29-day treatment period in participants with recurrent genital herpes.
Antiviral activity will be assessed by measuring changes in viral parameters, including HSV type 2 (HSV-2) shedding rate and levels of HSV-2 DNA, as well as clinical parameters such as days with lesions. ABI-1179 previously demonstrated positive interim Phase 1a results with a pharmacokinetic profile supporting once-weekly oral dosing.
To support concurrent enrollment with the ABI-5366 trial, Assembly Bio received clearance for an Investigational New Drug (IND) application for ABI-1179, allowing expansion of the Phase 1b study to sites in the United States. Interim data for both ABI-1179 and ABI-5366 Phase 1b studies are on track for fall 2025.
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