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Arrowhead Presents New ARO-HBV Clinical Data Demonstrating HBsAg Reductions at World Gastroenterologists Summit
Sep 6, 2018 at 7:30 AM EDT
Data presented from the lowest two dose cohorts (100mg and 200mg ARO-HBV) Up to 4.0 log10 reduction in HBsAg observed following three doses of ARO-HBV ARO-HBV was generally well-tolerated in HBV patients PASADENA, Calif. --(BUSINESS WIRE)--Sep. 6, 2018-- Arrowhead Pharmaceuticals Inc.
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Data presented from the lowest two dose cohorts (100mg and 200mg ARO-HBV)
Up to 4.0 log10 reduction in HBsAg observed following three doses of ARO-HBV
ARO-HBV was generally well-tolerated in HBV patients
PASADENA, Calif.--(BUSINESS WIRE)--Sep. 6, 2018-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) will present initial clinical data for ARO-HBV, the company’s third generation subcutaneously administered RNA interference (RNAi) therapeutic being developed as a potentially curative therapy for patients with chronic hepatitis B virus (HBV) infection, at the 18th World Gastroenterologists Summit in Auckland, New Zealand. Data will be presented from the eight patients in the lowest two dose cohorts: 100mg and 200mg. The data demonstrate that three monthly doses of ARO-HBV led to a maximum reduction in circulating HBV surface antigen (HBsAg) of 4.0 log10, with mean reductions of approximately 2.0 log10 on day 85 in the 100 mg cohort and 1.4 log10 on day 71 in the 200mg cohort (currently the last complete data point available). All eight patients achieved greater than 1.0 log10 reductions in circulating HBsAg.
Safety data will be presented across all ten patient cohorts (n=40). ARO-HBV was generally well-tolerated with generally mild and self-limiting injection site adverse events being the most common reported event in chronic HBV patients, occurring in around 10% of injections. The other most commonly reported events included symptoms consistent with upper respiratory tract infection and headache.
These results represent the first clinical data presented on ARO-HBV, which leverages Arrowhead’s proprietary Targeted RNAi Molecules (TRiMTM) platform. The company intends to submit a late-breaking abstract with additional clinical data to the Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held in November 2018.
Bruce Given, M.D., Arrowhead’s chief operating officer and head of R&D, said, “These initial results from the first two multiple-ascending dose cohorts of the AROHBV1001 clinical study are encouraging and indicate that ARO-HBV is highly active. In addition, the drug appears to be generally well-tolerated, which is consistent with our experience to date with ARO-AAT, our TRiMTM enabled candidate for the treatment of Alpha-1 liver disease. We intend to submit late-breaking abstracts to the AASLD Liver Meeting for both ARO-HBV and ARO-AAT, and, if accepted, we look forward to presenting more complete data-sets, including additional dose levels and longer follow-up.”
Key new data to be presented at the 18th World Gastroenterologists Summit from the AROHBV1001 Phase 1/2 clinical study in patients with chronic HBV who received three monthly doses of ARO-HBV include the following:
Mean reduction of HBsAg was 2.0 log10 (99%) on day 85 in cohort 2b (100 mg) and 1.4 log10 (96%) on day 71 in cohort 3b (200 mg)
These may not represent nadir
Maximum reduction of HBsAg was 4.0 log10 (99.99%)
Minimum HBsAg reduction in all patients from cohorts 2b and 3b was 1.2 log10 (93%)
Activity was demonstrated in all patient types (HBeAg pos/neg, NUC naïve/treated)
ARO-HBV appeared to be generally well-tolerated
The keynote presentation, titled “Hepatitis B in focus: new biology, new targets and real hope for finite therapy,” will be delivered by Dr. Given on September 7 at 09:45 a.m. NZST. A copy of the presentation (see slides 21-23) can be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.
AROHBV1001 (NCT03365947) is a Phase 1/2 study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and evaluating the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV. Dosing in the SAD portion of the study is complete, and included five cohorts at dose levels of 35, 100, 200, 300, and 400 mg. Dosing in the MAD portion of the study is ongoing, and includes ten cohorts receiving three doses of ARO-HBV either weekly, bi-weekly, or monthly, and includes dose levels of 100, 200, 300, and 400 mg.
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楼主: StephenW
发表于 2018-9-6 23:49
