First patient dosed in Assembly Biosciences’ phase 1b trial for hepatitis B treatment
Betsy Goodfellow | June 19, 2024 | News story | Research and Development | Assembly Biosciences, Hepatology, clinical trial, hepatitis
Assembly Biosciences has announced that the first participant has been dosed in its phase 1b trial of ABI-4334, the company’s next-generation capsid assembly modulator (CAM) candidate currently being developed for the treatment of chronic hepatitis B virus (HBV) infection.
The prior phase 1a assessed the once-daily oral dosing of ABI-4334, and demonstrated a favourable safety and pharmacokinetic (PK) profile in healthy participants. The trial demonstrated that ABI-4334 exposure levels were ‘projected to achieve strong antiviral activity and double-digit multiples over protein adjusted EC50 for both HBV DNA replication and cccDNA formulation,’ according to the press release.
The phase 1b trial is still enrolling patients, with the aim of assessing safety, PK and antiviral activity in individuals with chronic HBV infection over a 28-day treatment period.
Anuj Gaggar MD PhD, chief medical officer of Assembly Biosciences, commented: “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 chronic HBV. In this 28-day placebo-controlled study, we will be able to measure the impact of escalating doses of ABI-4334 on HBV DNA and refine the projected activity against cccDNA formation, along with generating key safety data. We look forward to reporting interim results from the study later this year.”
Betsy Goodfellow
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