Assembly Biosciences Reveals Positive Interim Results of ABI-4334

Assembly Biosciences Reports Positive Interim Results from Clinical Trial

Assembly Biosciences, Inc. has announced significant interim results from its Phase 1b clinical trial of ABI-4334, a next-generation capsid assembly modulator targeting chronic hepatitis B virus (HBV) infection. These results underscore the potential of this investigational therapy in changing the landscape for patients suffering from chronic HBV.

Strong Antiviral Activity Observed

The data reveals that participants in the initial 150 mg dose cohort experienced a substantial mean reduction of 2.9 log IU/mL in plasma HBV DNA over a treatment period of 28 days. This promising antiviral activity highlights ABI-4334's potential effectiveness in combatting chronic HBV, particularly amongst predominantly hepatitis B e antigen (HBeAg) negative subjects.

Safety and Tolerability of ABI-4334

Patients in the study reported high tolerability, with ABI-4334 demonstrating a favorable safety profile. No serious adverse events were documented, and the only grade three lab abnormalities observed resolved with continued dosing. These findings are crucial as they indicate that patients can tolerate ABI-4334 well, making it a potential candidate for further development.

Next Steps for ABI-4334 Development

Enrollment is actively underway for the final cohort, which will evaluate a higher dose of 400 mg. Initial data from the 150 mg cohort provide a strong rationale for the anticipated outcomes of the 400 mg group. Data from this cohort are expected in the early part of the upcoming year, setting the stage for future clinical developments.

Collaboration with Gilead Sciences

Assembly Biosciences is collaborating with Gilead Sciences under a partnership that allows Gilead the option to further develop and commercialize ABI-4334 upon the completion of this Phase 1b study. The collaboration is pivotal as it aims to advance the ongoing research for ABI-4334 and expand its potential market reach.

Overview of the Phase 1b Study

The clinical study, named ABI-4334-102, is designed as a randomized, blinded, placebo-controlled trial. Its primary goal is to evaluate the safety, pharmacokinetics, and antiviral activity of ABI-4334 over a treatment duration of 28 days. An impressive double-blind methodology ensures the integrity of the results and participant safety.

Implications for Chronic HBV Treatment

Chronic HBV remains a serious global health challenge, and therapies targeting the virus are crucial. The significant reduction in HBV DNA and RNA observed during the trial provides hope for improvement in treatment regimens for patients. ABI-4334 aims to fill a critical gap in chronic HBV management that can lead to improved patient outcomes.

About Assembly Biosciences

Assembly Biosciences is at the forefront of developing innovative small-molecule therapeutics for treating serious viral diseases. The dedicated team at Assembly Bio focuses on bringing transformative treatments to patients battling chronic infections, including HBV. With a commitment to improving patient outcomes, Assembly Biosciences continues to lead in virologic drug development.

Frequently Asked Questions

What is ABI-4334?

ABI-4334 is an investigational next-generation capsid assembly modulator designed to treat chronic hepatitis B virus infection.

How does ABI-4334's efficacy compare to current treatments?

The preliminary results indicate that ABI-4334 has strong antiviral activity, achieving significant reductions in HBV DNA levels in patients.

What safety profiles have been reported for ABI-4334?

ABI-4334 has shown a favorable safety profile, with no serious adverse events reported among participants in the initial trial.

When can we expect further results from the trial?

Data from the final 400 mg cohort is anticipated to be released in the first half of the upcoming year, which will provide insights into the drug's effectiveness at higher doses.

How does the collaboration with Gilead impact ABI-4334's future?

The collaboration with Gilead is crucial for further development and commercialization options, enhancing ABI-4334's potential market entry.

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