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Arrowhead Files to Begin Phase IIa Trial of HBV Drug


Arrowhead Research last month said that it has submitted a regulatory application seeking clearance to begin a phase IIa study of its RNAi-based hepatitis B treatment ARC-520.

ARC-520 comprises two distinct siRNAs targeting highly conserved genomic regions across the major HBV genotypes, and is formulated with a proprietary delivery technology called dynamic polyconjugates.

The planned phase IIa trial is slated to run in Hong Kong and test single, escalating doses of ARC-520 in combination with the antiviral entecavir in order to determine the "depth and duration of hepatitis B surface antigen reduction," according to Arrowhead.

In October, Arrowhead announced that preliminary phase I data showed the drug to be safe enough to advance into the next stage of human testing.