Electron micrograph of hepatitis-B virus. Credit: CDC.

Arrowhead Pharmaceuticals has dosed the first subject in a Phase I/II clinical trial of ARO-HBV for the treatment of patients with chronic hepatitis B virus (HBV) infection.

As part of the AROHBV1001 (NCT03365947) trial, Arrowhead will assess the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult subjects.

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The trial will also evaluate the safety, tolerability, and pharmacodynamic of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.

“Our experience with two prior compounds, ARC-520 and ARC-521, provides us with confidence that ARO-HBV has the potential to be a backbone therapy.”

The SAD portion of the trial aims to enrol up to five cohorts, with six subjects per cohort.

Each SAD subject will be given a single-dose administration of either placebo or ARO-HBV at up to five dose levels that include 35mg, 100mg, 200mg, 300mg and 400mg.

The MAD portion is set to include up to eight cohorts of four HBV patients per cohort, with each MAD patient receiving three doses of ARO-HBV at up to four dose levels featuring 100mg, 200mg, 300mg and 400mg.

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Arrowhead Pharmaceuticals chief operating officer and R&D head Bruce Given said: “The AROHBV1001 Phase I/II 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.”

ARO-HBV is Arrowhead’s second clinical candidate developed using the company’s proprietary Targeted RNAi Molecule (TRiMTM) technology.