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ABI-5366 is a novel, long-acting small molecule inhibitor targeting the helicase-primase complex of herpes simplex virus (HSV), specifically developed for the treatment of recurrent genital herpes. It acts by inhibiting the HSV helicase-primase complex, a clinically validated antiviral target essential for viral DNA replication. The drug demonstrates broad activity against both HSV type 1 (HSV-1) and HSV type 2 (HSV-2) clinical isolates, including strains resistant to nucleoside analogs. Preclinical and early clinical data show that ABI-5366 has an extended half-life of approximately 20 days in humans, supporting potential once-weekly or once-monthly oral dosing regimens. Interim Phase 1a results indicate that it is well tolerated with no serious adverse events reported at doses up to 350 mg orally. The developer is Assembly Biosciences[1][5][7][8].
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