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.