WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) announced it has received authorization from the U.S. Food and Drug Administration to proceed with its Investigational New Drug (IND) application for AB-729 in a Phase 2a clinical trial. The Phase 2a proof-of-concept clinical trial will evaluate the safety and efficacy of AB-729 in combination with ongoing nucleos(t)ide analog (NA) therapy and short courses of Peg-IFNα-2a in subjects with CHB.
William Collier, President and Chief Executive Officer of Arbutus, stated, “The acceptance of our IND application is an important step forward for AB-729 and supports our objective to establish its value as a cornerstone therapy for patients with CHB. We look forward to the initiation of this proof-of-concept Phase 2a clinical trial in this quarter.”
Gaston Picchio, PhD, Chief Development Officer at Arbutus, stated, “We are gratified that our IND submission for AB-729, in combination with Peg-IFN, in subjects with chronic hepatitis B viral infection has been deemed safe to proceed.
“This Phase 2a trial will allow us to investigate if short courses of Peg-IFN, following a pronounced HBsAg suppression and potential immune reactivation by AB-729, could contribute to achieving a functional cure in HBeAg negative chronic hepatitis B subjects.”
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