ABI-4334 Shines in Phase 1a Clinical Trial: Assembly Biosciences Highlights Positive Results and Pipeline Updates

Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company pioneering groundbreaking antiviral therapeutics, today revealed the results of the final multiple-dose cohort in the Phase 1a study of its highly potent hepatitis B virus (HBV) core inhibitor, ABI-4334 (4334).

Additionally, the company announced it will explore partnering opportunities for its core inhibitor portfolio and prioritize its extensive virology pipeline. With its cutting-edge solutions for serious viral diseases, Assembly Biosciences is on the forefront of developing innovative treatments and therapies.

Assembly Bio is thrilled about the promising clinical profile of their core inhibitor candidate 4334 and its potential to reach the clinical exposures needed for antiviral activity and cccDNA formation inhibition. The Phase 1b study of their next-generation core inhibitor, 3733, in HBV patients has also demonstrated strong antiviral activity.

However, longer-duration Phase 2 studies will be needed to demonstrate the ability of next-generation core inhibitors to inhibit cccDNA formation in the clinic. That is why they are seeking to partner their core inhibitor portfolio as it would enable more opportunities for further clinical development with the goal of achieving a functional cure for HBV, including possible combination approaches.

At Abivax, we are prioritizing our expanded virology pipeline to ensure we can make a near-term impact for patients and stockholders. Over the past three years, we have diligently crafted a diverse portfolio, designed to address significant unmet medical needs with shorter timelines to key inflection points and clinical proof of concept.

We anticipate entering the clinic with our first program candidate, the long-acting helicase inhibitor ABI-5366 for the treatment of high-recurrence genital herpes, during the first half of 2024, with a second program candidate soon to follow by the end of the year. We are confident that these investments will pay off in the near future.

Assembly Bio is excited to announce their expanded virology research pipeline for 2022, which focuses on cutting-edge programs to target and treat HBV, HDV, and herpesviruses. This reprioritization of programs has enabled Assembly Bio to extend their estimated cash runway into the third quarter of 2024. With these innovative and differentiated programs, Assembly Bio is driving advances in the fight against some of the world’s most challenging viruses.

4334 Clinical Data and Development Update

The Phase 1a clinical trial for 4334 (Study ABI-4334-101) is a groundbreaking study that seeks to evaluate the safety, tolerability and pharmacokinetics of 4334. Through innovative single and multiple ascending dose administration, this randomized, blinded and placebo-controlled trial will assess the proportion of subjects with adverse events, premature treatment discontinuation due to AEs and abnormal laboratory results. A comprehensive evaluation of 4334 is set to be conducted, providing vital insights into the drug’s usage and effects.

The study is now complete, with all dosing ranges and cohorts evaluated – from the single-dose cohorts of 30 mg, 100 mg, 200 mg and 400 mg to the multiple-dose cohorts of 100 mg and 200 mg, and finally the food effect cohort of 200 mg (data pending). It has been a comprehensive study, and the results are eagerly awaited.

A remarkable 4334 patients continued to demonstrate a half-life that could be successfully managed with a once-a-day dosing regimen. Furthermore, daily minimum plasma trough concentrations of the drug, within the range studied in the Phase 1a trial, were projected to be more than double-digit multiples of the protein-adjusted EC50 for both antiviral activity and against cccDNA formation. Notably, when administered at a dose of 200 mg per day, the drug was projected to surpass the 30 times protein-adjusted EC50 for cccDNA formation.

Overall, 4334 has been well-tolerated. Through April 17, 2023, any treatment-emergent AEs or laboratory abnormalities experienced were mostly mild, with only a few being moderate in severity. In addition, no patterns of AEs or laboratory abnormalities were attributed to 4334, and no clinically significant ECG abnormalities were reported.

Assembly Bio has internally discovered and developed ABI-4334, a highly potent antiviral that has been specifically designed to effectively fight against the formation of the viral reservoir, cccDNA, and the production of new virus particles. Its effectiveness makes it a promising solution for combating the virus.

About Assembly Biosciences

Assembly Biosciences is a clinical-stage biotechnology company that is revolutionizing the treatment of serious viral diseases. We are committed to improving the lives of patients worldwide through the development of innovative small molecule antiviral therapeutics.

Our pipeline consists of two complementary approaches to treat hepatitis B virus (HBV) and hepatitis delta virus (HDV) as well as two serious consequences associated with herpesvirus infections.

Our potent, next-generation HBV core inhibitors are designed to disrupt the virus’ replication cycle at multiple points with the goal of achieving finite treatment and functional cures. Led by a team of experienced virologic drug developers, Assembly Biosciences is dedicated to making a positive impact on the lives of those suffering from the chronic impacts of HBV, HDV, and herpesvirus infections.

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