Assembly Biosciences announced positive interim results from its Phase 1b clinical trial of ABI-5366, a long-acting helicase-primase inhibitor for recurrent genital herpes (HSV-2). Patients receiving a 350 mg weekly dose showed a 94% reduction in HSV-2 viral shedding and a 94% reduction in genital lesion rate compared to placebo, both statistically significant over a 29-day period14.
The results also revealed a 98% reduction in high viral load shedding rate, and ABI-5366 demonstrated a favorable safety and tolerability profile4.
The efficacy and safety profile surpassed predefined targets, with potential for convenient weekly, or possibly monthly, dosing regimens. This could offer a substantial improvement over current daily herpes therapies1.
These interim data have prompted Assembly Bio to expedite Phase 2 development, expected to commence by mid-2026, while a monthly dosing cohort and parallel studies with Gilead’s ABI-1179 are ongoing1.
Assembly’s collaboration with Gilead Sciences remains a key driver, with Gilead holding opt-in rights on HSV programs post-Phase 1b. In conjunction with these results, Gilead purchased an additional 2.3 million shares of Assembly Biosciences, signaling increased commitment to the partnership1.
Sources:
1. https://www.stocktitan.net/news/ASMB/assembly-biosciences-reports-positive-interim-results-from-phase-1b-vs77yghdbpeg.html
4. https://www.biospace.com/press-releases/assembly-biosciences-reports-positive-interim-results-from-phase-1b-clinical-study-of-long-acting-helicase-primase-inhibitor-candidate-abi-5366-showing-reductions-in-viral-shedding-rate-and-genital-lesion-rate-in-recurrent-genital-herpes