Arrowhead Pharmaceuticals announced that it has completed enrollment and dosing of all 5 planned cohorts of healthy adult volunteers in the single-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 hepatitis B virus (HBV) infection. The company intends to submit a late-breaking abstract with initial clinical data on ARO-HBV to the Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held in November.
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 included 5 cohorts of 6 subjects per cohort. Each SAD subject received a single-dose administration of either placebo or ARO-HBV at dose levels of 35, 100, 200, 300, or 400 mg. The MAD portion, which is ongoing, 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). The first 2 MAD cohorts at doses of 100 mg and 200 mg have been fully enrolled and the company anticipates that the third cohort at a dose of 300 mg will be enrolled shortly.