Arbutus Biopharma Corporation (NASDAQ: ABUS) has announced interim data from the ongoing Phase 1a/1b clinical study showing that its next-gen capsid inhibitor, AB-836 is safe and well-tolerated in healthy participants and cHBV patients and it offers a strong antiviral activity.
Preliminary AB-836 safety results
The company’s Chief Development Officer Gaston Picchio said, “These preliminary results demonstrate that AB-836 is generally safe and well-tolerated in both single- and multiple-doses in healthy subjects and at doses up to 100mg administered once daily for 28 days in cHBV patients. In addition, the mean Day 28 drop in HBV DNA observed to date with a relatively low dose suggests that AB-836 is a very potent inhibitor of HBV replication making it an ideal candidate to potentially completely suppress viral replication. We look forward to continuing to evaluate the safety and efficacy of AB-836 in Part 3 of this trial.”
AB-836 is an oral hepatitis B virus (HBV) capsid inhibitor of the next generation that interacts with the HBV core protein, which is necessary for viral replication. Nucleos(t)ide analogues, which inhibit the viral polymerase and considerably lower but do not abolish viral replication, are the current standard-of-care therapy for HBV. By blocking the construction of functional viral capsids, AB-836 in combination with nucleos(t)ide analogues is meant to eliminate viral reproduction in infected cells fully.
The study is divided into three sections
The Phase 1a/1b clinical trial aims to assess the pharmacokinetics, tolerability, safety, and antiviral efficacy of multiple and single AB-836 doses. The study is divided into three sections. In part one, healthy volunteers were given alternating single doses of AB-836 or placebo ranging from 10mg to 175mg in a fasting or fed state. Part 2 looked at healthy volunteers who were given multiple ascending dosages of 50mg, 100mg, or 150mg of AB-836 or placebo once a day for 10 days. Part 3 is still ongoing, and it is now randomizing HBV DNA positive cHBV patients who are HBeAg positive or negative to receive 50mg or 100mg of AB-836 or placebo once daily for 28 days.
