Investigational Hepatitis B Cure Therapy Begins Phase 1 Trial
The oral RNA destabilizer, AB-161, developed by Arbutus Biopharma, started dosing its first participant for the small trial.
Warminster, PA-based Arbutus Biopharma, a clinical-stage biopharmaceutical company, announced earlier this month that it had begun dosing its first participant for its phase 1 trial looking at its hepatitis B (HBV) developmental therapy for a functional cure.
“We are pleased to move AB-161 into Phase 1 clinical development,” said William Collier, president and CEO of Arbutus Biopharma. “AB-161 was designed to reduce HBsAg levels and inhibit viral replication by selectively inhibiting essential host proteins that are important in stabilizing HBV RNAs from degradation.”
The company is performing a phase 1 double-blind, randomized, placebo-controlled, clinical trial is designed to investigate the safety, tolerability, and pharmacokinetics of oral administration of AB-161 in healthy subjects. The trial will enroll unique cohorts of ten healthy subjects each (8 active, 2 placebo) to receive single doses of AB-161.
Safety assessments will be performed continuously and after day 7, if acceptable, the next cohort of subjects will be enrolled to receive an escalated dose of AB-161. A food effect assessment will also be conducted at a dose considered safe and well-tolerated and close to the anticipated therapeutic dose in chronic HBV patients.
AB-161 is an oral, small molecule RNA destabilizer, specifically designed to target the liver. RNA destabilizers target the host proteins PAPD5/7, which are involved in regulating the stability of HBV RNA transcripts. In doing so, RNA destabilizers lead to the selective degradation of HBV RNAs, thus reducing HBsAg levels and inhibiting viral replication.
The company expects the initial data from this phase 1 single-ascending dose clinical trial in healthy subjects are expected later this year. “We remain committed to advancing our pipeline of assets to develop a functional cure for chronic HBV and look forward to sharing the initial data from the phase 1 clinical trial of AB-161 in the second half of 2023,” Collier said.
