Business
Assembly Biosciences Nominates First Herpesvirus Development Candidate ABI-5366, a Long-Acting HSV-2 Helicase Inhibitor Targeting High-Recurrence Genital Herpes
−ABI-5366 Demonstrates Favorable Profile for a Long-Acting Therapeutic in Preclinical Studies −IND-Enabling Studies Initiating for 5366, Supporting
About this update from Assembly Biosciences, Inc.
[{"type":"text","content":"−ABI-5366 Demonstrates Favorable Profile for a Long-Acting Therapeutic in Preclinical Studies −IND-Enabling Studies Initiating for 5366, Supporting Anticipated IND/CTA Filing in 1H2024 SOUTH SAN FRANCISCO, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced the selection of development candidate ABI-5366 (5366) to progress to IND-enabling studies for its long-acting herpes simplex virus type 2 (HSV-2) helicase inhibitor program. 5366 is the first development candidate from Assembly Bio’s discovery pipeline nominated for advancement to clinical development since the company announced its expanded research focus outside of hepatitis B last year. “We’re excited to bring forward this novel development candidate from our HSV-2 program targeting high-recurrence genital herpes, a serious chronic viral disease with profound physical and psychological impacts on patients. There has not been a new medicine approved for patients suffering from high-recurrence genital herpes in decades and current therapies are only partially effective in preventing frequent outbreaks,” said William Delaney, PhD, chief scientific officer of Assembly Bio. Assembly Bio’s HSV-2 program targets the viral helicase-primase, an essential viral enzyme complex and a clinically validated target. Helicase inhibition has demonstrated greater reductions in HSV-2 shedding, lesions and pain compared to approved suppressive nucleoside analog regimens in previous clinical studies. 5366, a small molecule helicase inhibitor with nanomolar potency in vitro, is designed for long-acting administration and has shown favorable pharmacokinetics (PK) for a long-acting therapeutic, including the key property of exceptionally low clearance, in preclinical studies. 5366’s preclinical profile shows the potential for at least monthly dosing, and Assembly Bio will continue to evaluate longer dosing intervals as development and formulation progress. “Assembly Bio’s differentiated long-acting approach for HSV-2 offers the potential to maintain optimal drug plasma concentrations over long periods of time. We anticipate this drug profile, supported by 5366’s remarkably low clearance, will enhance both adherence and antiviral act...