TUESDAY, SEPTEMBER 27, 2016

ARC successfully completes Phase I trial of hepatitis B drug ARC-520

Arrowhead Research Corporation announced on Wednesday that it successfully completed enrollment in a Phase I clinical trial of its RNAi-based candidate drug, ARC-520, against chronic hepatitis B virus infection.

The preliminary testing showed that ARC-520 is generally well tolerated and safe for people in each of its six dose levels. ARC, a biopharmaceutical company which targets RNAi treatments, expects to begin a pilot Phase II study to observe how ARC-520 responds in chronic HBV patients.

"We are very pleased with these results and the pace at which we were able to complete the Phase 1 study," ARC President and Chief Executive Officer Christopher Anzalone said. "This positive readout on safety and tolerability of ARC-520 and the Dynamic Polyconjugate delivery platform has broad implications for Arrowhead. It gives us additional confidence as we move into an upcoming Phase 2a study and we believe it represents a key de-risking event for expanding our pipeline of RNAi therapeutics based on the DPC platform."

The Phase I trial aimed to design the safety profile of ARC-520 in various doses and pharmacokinetics. The trial was single-center, double-blind, randomized, placebo-controlled and done in single dose-escalation. It was the first human study of ARC-520 issued intravenously; all volunteers were healthy.

The Phase I trial proved to be safe for all subjects, although some subjects experienced upper respiratory infections. Follow-up on participants is ongoing. The pilot Phase 2a will take place in Hong Kong.