Healthy volunteer study will inform development of 4334 for treatment of hepatitis B virus
4334 is an investigational next-generation core inhibitor that is optimized for significantly increased potency against covalently closed circular DNA (cccDNA) formation and new virus production versus first-generation core inhibitors. In preclinical research, 4334 has demonstrated sub-nanomolar potency against pgRNA encapsidation and 2-3 nanomolar potency against cccDNA formation. Chronic HBV infection is a debilitating disease of the liver that is estimated to impact approximately 296 million people worldwide. HBV is the leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.
“The initiation of this first-in-human clinical trial for our investigational next-generation core inhibitor 4334, our most potent core inhibitor, marks a significant milestone in advancing toward our goal of delivering novel finite and curative therapies for HBV that target multiple steps during viral replication to suppress the production of new virus, particularly the formation of new cccDNA, the viral reservoir,” said
The Phase 1a clinical trial is a randomized, blinded and placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics of 4334 following single ascending dose and multiple ascending dose administration in healthy participants. The objectives of the study include the proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results. Results of the trial will support dose selection for a future Phase 2 trial.
Additional information about the trial is available at clinicaltrials.gov using the identifier NCT05569941. Data from the preclinical research program that supported clinical advancement for 4334 was recently presented at The Liver Meeting® hosted by the
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company pioneering the development of novel therapeutics for serious viral diseases. Assembly Bio is advancing a leading portfolio of more potent, next-generation core inhibitor drug candidates that aim to break the complex viral replication cycle of hepatitis B virus (HBV) to achieve finite and potentially curative therapies for the 296 million people living with HBV worldwide. The company’s research pipeline includes differentiated antiviral approaches against HBV/hepatitis delta virus and herpesviruses. For more information, visit assemblybio.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to successfully execute its previously announced reprioritization and restructuring activities, including the CEO transition; potential adverse legal, reputational, operational and financial effects on Assembly Bio resulting from the reprioritization and restructuring activities; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; continued development and commercialization of ABI-H3733, if successful, in the
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