Assembly Bio Selects Fourth HBV Core Inhibitor Candidate for Advancement Into Clinical Development


Assembly Biosciences, Inc. recently announced it has selected a fourth core inhibitor candidate, ABI-4334 (4334), that has been optimized for potency, to advance into clinical development. The company is conducting preclinical work, with the aim of completing regulatory filings and initiating clinical studies as soon as possible in 2022.

“In our mission to deliver finite and curative therapies to individuals with HBV, we have always been committed to developing the most promising candidates, specifically those with the profile to achieve greater, and potentially complete, viral suppression in patients,” said William Delaney, PhD, Chief Scientific Officer of Assembly Bio. “We believe ABI-4334 has a best-in-class preclinical profile with single-digit nanomolar potency against the production of new virus and also the formation of cccDNA. We’re excited to further evaluate this compound and its potential, as we plan for the start of clinical studies next year.”

Assembly Bio selected 4334 based on a preclinical target drug profile that indicates enhanced target coverage and potency to prevent both formation of new virus and covalently closed circular DNA (cccDNA), which is responsible for maintaining the HBV viral reservoir. Preclinically to date, the candidate has also demonstrated pan-genotypic activity, an improved resistance profile, pharmacokinetics (PK) predicting once-daily dosing and a favorable safety profile.

Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. For more information, visit assemblybio.com.