Business
Arbutus Announces Positive Preliminary Phase 1a/1b Clinical Trial Results for AB-729, a Proprietary GalNAc Delivered RNAi Compound in Development for People Living with Chronic Hepatitis B
Positive single dose AB-729 data in chronic hepatitis B subjects supports further clinical development First multiple dose cohort results expected in second
About this update from Arbutus Biopharma Corporation
[{"type":"text","content":"Positive single dose AB-729 data in chronic hepatitis B subjects supports further clinical development\n First multiple dose cohort results expected in second half of 2020 One or more additional single dose cohorts planned to further optimize antiviral response and dosing frequency with results expected in the second half of 2020 Conference call and webcast scheduled today at 4:30 PM ET WARMINSTER, Pa., March 26, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced positive preliminary results from a Phase 1a/1b clinical trial (AB-729-001) in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy, all of whom received a single subcutaneous injection of AB-729. AB-729-001 is an ongoing Phase 1a/1b clinical trial designed to determine the most effective dose and dosing interval for use in future Phase 2 combination clinical trials. William Collier, President and Chief Executive Officer of Arbutus, stated, “These encouraging preliminary results demonstrate that AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels and support its further development as a treatment for people living with chronic hepatitis B. Our plan is to move forward into the multiple dose portion of the clinical trial with the 60 mg dose and, in parallel, to explore additional single dose cohorts beginning with the 90 mg dose. We intend to initiate these cohorts as soon as possible; however, at this point, it is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines. Provided we can execute our clinical trials as planned, we continue to expect these data sets in the second half of the year.” Mean HBsAg changes from baseline: 60 mg Cohort (N=6)180 mg Cohort (N=4)Day 29 mean log10 IU/mL (SE)-0.24# (0.13)-0.81* (0.38)Week 12 mean log10 IU/mL (SE)NA-0.98 (0.22) #In the 60 mg cohort, the maximum Day 29 decline was -0.62 log10. *In the 180 mg cohort, excluding one subject with a HBsAg decline of -1.94 log10, the mean (SE) reduction for the remaining 3 subjects was -0.44 log10 (0.07) at Day 29 and -0.77 log10 (0.06) at Week 12. Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, “AB-729 dosed at either 60 mg or 180 mg in chronic hepatitis B subjects was generally saf...