PASADENA, Calif., May 14, 2018 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first 3 hepatitis B virus (HBV) patients in the multiple-ascending dose portion of its ongoing Phase 1/2 study of ARO-HBV, the company’s third generation subcutaneously administered RNA interference (RNAi) therapeutic being developed as a potentially curative therapy for patients with chronic HBV infection. Arrowhead has also dosed a total of 20 healthy volunteers (13 with ARO-HBV and 7 with placebo) since the study began on March 27. The company intends to submit a late-breaking abstract to present initial clinical data on ARO-HBV, if accepted, at the Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held in November. ARO-HBV leverages Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) technology.
Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead, said, “Our Phase 1/2 study of ARO-HBV is designed to rapidly generate meaningful readouts on safety, tolerability and pharmacologic activity. The single-ascending dose and multiple-ascending dose phases are running nearly in parallel, as opposed to sequentially, which has allowed dose escalation and initiation of HBV patient dosing quickly. The results of this study should provide us with insight into ARO-HBV as a potentially important component of curative therapy for patients with chronic HBV infection.”
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).
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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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.