Arrowhead Doses First Hepatitis B Patients in Multiple Dose Portion of Phase 1/2 Study of ARO-HBV
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.
The SAD portion is designed to include up to 5 cohorts of 6 subjects per cohort. Each SAD subject will receive a single-dose administration of either placebo or ARO-HBV at up to 5 dose levels (35, 100, 200, 300, 400 mg). The MAD portion is designed to include up to 8 cohorts of 4 HBV patients per cohort. Each MAD patient will receive 3 doses of ARO-HBV at up to 4 dose levels (100, 200, 300, 400 mg).
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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
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