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Arbutus Announces Single-Dose Week 12 Data in Chronic Hepatitis B Subjects with 60 mg AB-729 Demonstrating a Significant and Continuous Reduction in HBsAg
Published: May 18, 2020
WARMINSTER, Pa., May 18, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today reports positive follow-up data from a Phase 1a/1b clinical trial (AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc delivered RNAi compound.
William Collier, President and Chief Executive Officer of Arbutus, stated, “These new data further demonstrate the robust activity of AB-729. At week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single-dose. We are currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg of AB-729. These data keep us on track for achieving our goal of delivering a combination therapy that includes HBsAg reduction in chronic hepatitis B subjects.”
Mean HBsAg changes from baseline:
60 mg Single-Dose Cohort
(N=6) 180 mg Single-Dose Cohort
(N=4)
Day 29 mean log10 IU/mL
(Standard Error of the Mean) -0.24 (0.13) -0.8 (0.38)
Week 12 (day 84) mean log10 IU/mL
(Standard Error of the Mean) -0.99 (0.24) -0.98 (0.22)
Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, “Importantly, throughout the 12 week period, not only does AB-729 demonstrate robust HBsAg reduction, it does so while remaining generally safe and well tolerated with no abnormal transaminase values in any of the six subjects.”
Dr. Picchio added, “We are impressed by both the magnitude and continuous reduction in HBsAg achieved with a single 60 mg dose. We believe that these features could provide a competitive advantage with a low dose and reduced frequency of injections. To this end, we are currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg at 4 week intervals and also intend to evaluate 60 mg at 8 week intervals, which will begin as soon as possible. As we previously announced we are also exploring an additional 90 mg single-dose cohort. We expect data from both the 60 mg multi-dose cohorts in the second half of the year. We also expect week 12 90 mg single-dose data in the second half of 2020.”
Summary of clinical trial design
AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:
In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.
In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg or 180 mg) of AB-729. An additional cohort in Part 2 is designed to include 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.
In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, will receive multi-doses of AB-729 for up to six months.
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发表于 2020-5-20 18:51
