Chronic HBV (cHBV) infection is a leading cause of chronic liver disease and liver transplants globally, with the
In a Phase 1a study, once-daily oral dosing with ABI-4334 demonstrated a favorable safety and pharmacokinetic (PK) profile in healthy participants, with ABI-4334 exposure levels projected to achieve strong antiviral activity and double-digit multiples over protein adjusted EC50 for both HBV DNA replication and cccDNA formation. In vitro, ABI-4334 has shown single-digit nanomolar potency against both mechanisms of action and the ability to impact HBV DNA integration. The Phase 1b study that is currently enrolling will evaluate safety, PK and antiviral activity in individuals with cHBV infection over a 28-day treatment period.
“We believe ABI-4334 has the potential to demonstrate best-in-class antiviral activity in line with the very high potency seen preclinically and are pleased to initiate dosing for this differentiated investigational therapy in individuals with cHBV,” said
About ABI-4334-102
ABI-4334-102 is a randomized, blinded and placebo-controlled dose-ranging Phase 1b study that will evaluate the safety, PK and antiviral activity of ABI-4334 in participants with cHBV infection.
Participants may be treatment-naïve or off-treatment and hepatitis B e antigen (HBeAg) positive or negative. The dose-escalation trial will enroll up to five sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 between ABI-4334 and placebo with a treatment period of 28 days.
The objectives of the study include assessments of safety, tolerability and PK for ABI-4334, as well as changes in HBV DNA associated with ABI-4334 treatment. The results of the trial will support dose selection for future clinical trials.
Additional information about the trial is available at clinicaltrials.gov using the identifier NCT06384131. ABI-4334 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established.
About Assembly Biosciences
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 realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical 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; and other risks identified from time to time in Assembly Bio’s reports filed with the
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