Assembly Biosciences announced the most exciting results of the first phase 1a clinical trial of their most advanced helicase primase inhibitor, ABI-5366 (registered as clinical trial NCT06385327). The results exceeded expectations. ABI-5366 was well tolerated and presented a pharmacological profile that supports potential once-weekly or even once-monthly dosages. The trial included four cohorts, dosed at 10, 30, 100, or 350 mg randomized 6:2 treatment to placebo, and a fifth cohort that evaluates any effects of food intake. The study was designed for a follow up of 70 days, but it has been extended now to 100 days, considering the long half-life. The safety results to date are up to 70 days for the lowest dosage and 8 days for the highest and slightly shorter for the pharmacodynamics studies. Half-life was about 20 days (oral dosage). No serious adverse effects have been observed, no clinical ECG events, no level 3-4 laboratory abnormalities, and no protocol defined stop criteria were reached in any patient.
The continuing Phase 1b clinical study has been announced in HSV-2 seropositive patients with recurrent genital infection. The trial will include multiple ascending weekly and monthly doses over a treatment interval of 29 days. Beyond continuing analyzing safety and pharmacological characteristics, this trial will also perform a preliminary analysis of antiviral therapeutic effects, including viral shedding and lesion recurrence and duration. This trial is recruiting. For more information, please refer to clinicaltrials.org (NCT06385327) or contact Assembly Biosciences directly (https://www.assemblybio.com; info@assemblybio.com)
Assembly Biosciences is very excited about the results of the progress. CSO Dr. William Delaney expressed it as “The team here at Assembly Bio recognizes the urgent need for new treatments for people living with recurrent genital herpes. We are incredibly excited about these interim Phase 1a results for our investigational candidate ABI-5366 – these early data support the long-acting profile we are striving for and ABI-5366’s progression to further clinical evaluation. We are currently enrolling the phase 1b part of the study as quickly as possible with a goal of sharing preliminary data on treatment efficacy in the first half of next year.”
Give Today and Join the Fight →
Every donation – whether $10 or $10,000 – moves us closer to a world where herpes is effectively treated and free from stigma.
Questions about giving? Contact us at info@herpescureadvocacy.com or 267-797-7139.
Want the latest news on herpes cure, treatment and prevention?
Sign up for our newsletter and make sure you never miss a thing.
Sounds very promising. Hope they can accelerate development.