In preclinical studies, the next-generation core inhibitor 3733 showed significant increase in potency against covalently closed circular DNA (cccDNA) formation as well as the production of new virus compared to the first-generation inhibitors.
The double-blind, randomised, placebo-controlled, multi-centre Phase Ib clinical trial has been designed to assess the pharmacokinetics, antiviral activity, and safety of 3733 in adult patients with cHBV infection.
It builds upon the data obtained from the previous Phase Ia study which demonstrated 3733’s favourable safety and pharmacokinetic profile.
The Phase Ib trial will evaluate a new tablet formulation with the potential for a once-daily dosing.
About 50 cHBV infection patients who are treatment naïve or off treatment will be recruited for the dose-escalation trial.
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Later, the subjects will be randomised into 8:2 ratio and receive the new tablet formulation of 3733 and placebo for 28 days.
The study’s objectives include changes in HBV DNA as well as other viral parameters associated with 3733.
Assembly Biosciences CEO and president John McHutchison said: “We look forward to better understanding the safety profile and impact of activity of this novel, next-generation core inhibitor candidate in patients with chronic HBV infection through this trial.
“This study initiation serves as an important milestone in the clinical development program for 3733, a promising candidate that has demonstrated increased potency against both HBV core inhibitor mechanisms and against cccDNA formation in particular and advances our strategy to pursue finite and curative HBV therapies.”
The company stated that the data from the trial will support the dose selection for a Phase II study in the future.