Arbutus Announces AB-729 90 mg Single-Dose Week 12 Data in Chronic Hepatitis B Subjects Demonstrating Significant and Continuous Reductions in HBsAg
Mean HBsAg reduction of 1.23 log10 IU/mL at week 12 with a favorable safety and tolerability profile
WARMINSTER, Pa., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today reports continued positive data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. These new data demonstrate that in chronic HBV subjects, a single subcutaneous injection of 90 mg of AB-729 resulted in a mean HBsAg reduction of 1.23 log10 IU/mL at week 12.
William Collier, President and Chief Executive Officer of Arbutus, stated, “The 90 mg single-dose 12-week data coupled with our previously disclosed 60 mg single-dose 12-week data mean that we now have two doses which have demonstrated meaningful reductions in HBsAg with a favorable safety and tolerability profile. We are currently dosing chronic HBV subjects in four multi-dose cohorts using both the 60 mg (every 4- and 8-weeks) and 90 mg (every 8- and 12-weeks) doses to determine the optimal dosing regimen for AB-729. We believe AB-729 will potentially offer people with chronic HBV a well-tolerated low dose treatment with a minimum of injections.”
Arbutus expects to present initial results from its ongoing Phase 1a/1b clinical trial for the 60 mg multi-dose cohorts, the 90 mg single-dose cohort in HBV DNA positive subjects, as well as longer-term follow up of the 60 and 90 mg single-dose cohorts, at an upcoming scientific meeting later this year. In addition to the ongoing 60 mg multi-dose cohorts with subjects dosed at 4- and 8-weeks, the Company has also initiated 90 mg multi-dose cohorts with subjects dosed at 8- and 12-week intervals.
Mean HBsAg changes from baseline:
60 mg Single-Dose
90 mg Single-Dose
Week 12 (day 84) mean log10 IU/mL
(Standard Error of the Mean)
|-0.99 (0.24)||-1.23 (0.18)|
Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, “The mean HBsAg decline seen in the 90 mg single-dose cohort is consistent with that seen in prior single-dose cohorts. Importantly, the data demonstrate consistent efficacy and a favorable safety profile at this intermediate dose. These findings support the continued evaluation of the 90 mg dose in the multi-dose portion of our ongoing clinical trial.”