ABI-5366 / Assembly Biosci - LARVOL DELTA

Evaluation of the patent portfolio for helicase-primase inhibitor ABI-5366 of Assembly biosciences inc. (PubMed, Expert Opin Ther Pat) - P1 | "With amenamevir already approved for varicella-zoster virus and herpes simplex in Japan and with pritelivir's granted breakthrough therapy designation for the treatment of acyclovir-resistant HSV infections in immunocompromised patients, the target has sparked interest in helicase-primase inhibitors...This me-too approach on the old Bayer urea series is currently in clinical phase I (NCT06385327) and the modification is the bridging of the two urea nitrogens via an alkylene linkage. The chemical structure for 1,3-disubstituted tetrahydropyrimidin-2(1 H)-one derivative ABI-5366 is presented and its potential opportunities and limitations as a long-acting oral administration or injectable depot drug compared to other HPIs are discussed."

Journal • Herpes Simplex • Herpes Zoster • Infectious Disease • Varicella Zoster

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes (clinicaltrials.gov) - P1 | N=146 | Recruiting | Sponsor: Assembly Biosciences | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Herpes Simplex • Infectious Disease

Preclinical profile of ABI-5366, a novel potent HSV helicase-primase inhibitor, with potential for weekly or monthly oral dosing for the treatment of recurrent genital herpes (ESCMID Global 2025) - No abstract available

Preclinical • Infectious Disease

The safety and pharmacokinetics of ABI-5366, a novel, oral, long-acting HSV helicase-primase inhibitor: Interim results from a Phase 1a/1b study in healthy participants (ESCMID Global 2025) - No abstract available

Clinical • P1 data • PK/PD data

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes (clinicaltrials.gov) - P1 | N=146 | Recruiting | Sponsor: Assembly Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Herpes Simplex • Infectious Disease

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes (clinicaltrials.gov) - P1 | N=146 | Not yet recruiting | Sponsor: Assembly Biosciences

New P1 trial • Herpes Simplex • Infectious Disease