PASADENA, Calif., Apr 01, 2014 (BUSINESS WIRE) --
Arrowhead Research Corporation
ARWR
+10.40%
, a biopharmaceutical
company developing targeted RNAi therapeutics, today announced that the
first cohort of 8 patients has been fully enrolled and dosed in a Phase
2a clinical trial of ARC-520, its RNAi therapeutic for the treatment of
chronic hepatitis B virus (HBV) infection. The trial remains on schedule
to meet the previously stated goal of completing dosing in the second
quarter and releasing top line results in the third quarter.
“The pace of patient accrual for the ARC-520 Phase 2a study has been
very encouraging with the first dose group being enrolled and dosed in
just over a week,” said Christopher Anzalone, Ph.D., Arrowhead’s
President and CEO. “According to the study protocol, we expect to begin
dosing the next cohort in May and remain confident that we can release
top line data in the third quarter. ARC-520 has the potential to be the
first drug candidate ever to demonstrate consistent hepatitis B surface
antigen reduction in humans, which is thought to be critical in
achieving a functional cure for chronic HBV.”
The Phase 2a study is planned to enroll up to 16 chronic HBV patients in
two dose cohorts with patients receiving either ARC-520 or placebo in
combination with entecavir. The study is designed to evaluate the depth
and duration of hepatitis B surface antigen decline, among other
measures, in response to a single dose of ARC-520.
Arrowhead also announced that Zhen Li, Ph.D. has joined Arrowhead as
Vice President of CMC and Manufacturing. Dr. Li will have overall
leadership responsibilities for analytical methods development, process
development, scale up, and production of all precursors, drug substance
and drug product for the Company’s development candidates.
“Zhen’s experiences at Merck and Novartis will provide a strong
foundation for Arrowhead to build global sourcing capabilities for our
RNAi drug candidates”, said Bruce D. Given, MD, Arrowhead’s COO. “This
hiring is a key component of our plans to build a multi-program pipeline
of RNAi therapeutics based on Arrowhead’s DPC delivery technology.”
Prior to joining Arrowhead, Dr. Li was at Merck & Co., where she was a
leader in RNAi Therapeutics, Process Chemistry and was responsible for
research synthesis and supply chains for all siRNA delivery technologies
and siRNA active substances. Dr. Li has also held leadership positions
at Novartis and Schering Plough Pharmaceuticals.
Labels: ARC-520, clinical trials