Assembly Biosciences Starts Phase 1a/b Trial of Herpes Simplex Virus Inhibitor ABI-5366

Assembly Biosciences, a biotechnology firm focused on creating advanced treatments for serious viral diseases, has commenced the Phase 1a/b clinical trial for ABI-5366, their innovative helicase-primase inhibitor aimed at treating recurrent genital herpes. This marks a significant milestone in the development of the drug, which has shown promising results in preclinical studies.

Study Design and Objectives

The clinical trial for ABI-5366, known as ABI-5366-101, is structured into two parts: Phase 1a and Phase 1b. The initial Phase 1a involves single ascending dose trials in healthy participants to evaluate the safety, tolerability, and pharmacokinetics (PK) of the drug. In this segment, the participants are randomized in a 6:2 ratio between ABI-5366 and a placebo across up to five different dose cohorts.

Upon completion of the Phase 1a trials, the study will transition directly into Phase 1b by the end of 2024, involving individuals who are seropositive for HSV-2 and suffer from recurrent genital herpes. The Phase 1b trial will explore multiple ascending dose administrations over a 29-day period, with participants randomized in a 20:5 ratio between ABI-5366 and placebo across four dose cohorts.

Potential Impact and Mechanism

ABI-5366 has demonstrated nanomolar potency against both HSV-1 and HSV-2 in vitro, suggesting its potential for long-acting administration. The drug aims to address the limitations of current treatments for recurrent genital herpes, which are often only partially effective despite daily use. Current therapies fail to prevent recurrences in a significant portion of patients, with only 34% remaining recurrence-free over a year.

Dr. Anuj Gaggar, Chief Medical Officer of Assembly Bio, emphasized the importance of this advancement, noting that no new therapeutic options have emerged for recurrent genital herpes in over 25 years. The HSV helicase-primase is a validated target, and the data from Phase 1a will be crucial in assessing the drug’s ability to achieve target concentrations for antiviral efficacy and support a once-weekly dosing regimen. This will inform dose selection for the subsequent Phase 1b trials.

Future Directions and Clinical Significance

The Phase 1b trials will not only assess the safety, tolerability, and PK but also evaluate antiviral efficacy. Metrics such as viral shedding rates, HSV-2 DNA levels, lesion recurrence, and lesion duration will be measured to provide a comprehensive understanding of ABI-5366's therapeutic potential. Successful results could pave the way for a Phase 2 trial.

Assembly Biosciences' focus on advancing ABI-5366 highlights their commitment to addressing unmet medical needs in the field of viral diseases. By providing a potentially more effective treatment option for recurrent genital herpes, the company aims to improve the quality of life for millions affected by this condition.

Conclusion

ABI-5366 represents a promising development in the treatment of recurrent genital herpes, offering hope for more effective management of the condition. The ongoing Phase 1a/b trials will provide critical data on the drug’s safety, tolerability, and efficacy, setting the stage for further clinical development and potentially offering a new therapeutic option for a condition that has seen little innovation in recent decades.

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