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.

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.

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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.

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.