Assembly Biosciences(US:ASMB) Globenewswireยท2025-10-10 12:00Core Insights - Assembly Biosciences, Inc. presented interim Phase 1b clinical data for its HSV helicase-primase inhibitor candidate ABI-5366 at the IUSTI Congress, highlighting its potential to improve treatment for recurrent genital herpes [1][2] Clinical Data Summary - The interim data showed significant antiviral activity, with a 94% reduction in HSV-2 shedding rate, a 98% decrease in high viral load shedding rate, and a 94% reduction in genital lesion rate in the 350 mg weekly dosing cohort compared to placebo [3][9] - ABI-5366 was well tolerated at both the 30 mg and 350 mg doses evaluated in the study [2][3] Future Development Plans - A monthly dosing regimen of ABI-5366 is currently under evaluation, and interim data from both ABI-5366 and ABI-1179 studies are expected to be shared later this fall [4][9] - The company plans to initiate Phase 2 clinical studies of ABI-5366 in mid-2026 [4] Collaboration and Licensing - Under a collaboration agreement with Gilead Sciences, Gilead has the option to obtain an exclusive license for further development and commercialization of the helicase-primase inhibitor program after reviewing the data package post-Phase 1b studies [6][7] Market Context - Recurrent genital herpes affects over four million people in the U.S. and several European countries, with current treatment options being limited and no new therapies approved in over two decades [8][10] - The current standard of care is nucleoside analogs, which are only partially effective in preventing recurrences and reducing transmission [10][11]