Phase 1/2 study evaluates safety, tolerability of multiple-ascending doses of ARO-HBV in hepatitis B patients

May 14 2018

Arrowhead Pharmaceuticals Inc. 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).