Arrowhead Presents New ARO-HBV Clinical Data Demonstrating HBsAg Reductions at World Gastroenterologists Summit
- 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
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
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.
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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Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
Investors and Media:
LifeSci Advisors, LLC