Arrowhead Begins Dosing in Phase 1/2 Study of ARO-HBV for Treatment of Chronic Hepatitis B

Arrowhead Pharmaceuticals announced that it has dosed the first subjects in a Phase 1/2 clinical study of ARO-HBV, which is being developed as a potentially curative therapy for patients with chronic hepatitis B virus (HBV) infection. ARO-HBV is the second clinical candidate developed using Arrowhead’s proprietary Targeted RNAi Molecule (TRiMTM) technology.

Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead, said, “We are proud of how quickly ARO-HBV moved through preclinical studies and are excited to be starting first-in-human clinical studies. The AROHBV1001 Phase 1/2 clinical study has an innovative design that is intended to assess, in parallel, safety and tolerability in healthy volunteers and multiple-dose anti-viral activity in HBV patients. Our experience with two prior compounds, ARC-520 and ARC-521, provides us with confidence that ARO-HBV, which is designed to target all viral transcripts, including those produced by both cccDNA and HBV DNA integrated into host DNA, has the potential to be a backbone therapy in combinations aimed at achieving a functional cure of 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 to evaluate 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).