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Assembly Biosciences Presents New Data Highlighting Herpes Simplex Virus Development Candidate ABI-5366 at the 47th Annual International Herpesvirus Workshop
-- First presentation of preclinical data describing the activity, pharmacokinetics and safety profile of ABI-5366, supporting planned clinical entry in 1H
About this update from Assembly Biosciences, Inc.
[{"type":"text","content":"-- First presentation of preclinical data describing the activity, pharmacokinetics and safety profile of ABI-5366, supporting planned clinical entry in 1H 2024 -- SOUTH SAN FRANCISCO, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced data from development candidate ABI-5366, a long-acting herpes simplex virus (HSV) helicase inhibitor targeting high-recurrence genital herpes, featured in one oral and one poster presentation at the 47th Annual International Herpesvirus Workshop in Missoula, Montana, taking place July 15-19, 2023. “We are excited to present data for the first time highlighting the preclinical characterization of our development candidate ABI-5366, including its potent antiviral activity against both HSV-1 and HSV-2 and remarkable sustained plasma concentrations after both oral and subcutaneous dosing,” said William Delaney, PhD, chief scientific officer of Assembly Bio. “These promising results support the potential of ABI-5366 as a long-acting therapeutic for those suffering from high-recurrence genital herpes, a patient population that has been without advancements in treatment for far too long. We have initiated GLP toxicology studies and anticipate entering the clinic in the first half of next year.” In both the oral and poster presentation entitled “Pre-clinical characterization of ABI-5366: a highly potent long-acting helicase-primase inhibitor for the treatment of high recurrence genital herpes,” data describe ABI-5366’s low-nanomolar potency in vitro against both HSV-1 and HSV-2 clinical isolates. Supporting ABI-5366's potential as a long-acting therapeutic, data also demonstrate ABI-5366's low plasma clearance rates in multiple preclinical models with an extremely low projected clearance rate in humans. Additionally, in multiple preclinical models, oral dosing or subcutaneous injection of ABI-5366 demonstrated sustained plasma concentrations for greater than one month. The presentations also include non-GLP safety data available to date supporting a favorable safety profile for ABI-5366 with high exposure margins and minimal potential for off-target effects. Assembly Bio plans to initiate a Phase 1a study for ABI-5366 in the first half of 2024. Subsequen...