Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients
PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today announced that it
submitted an Investigational New Drug (IND) application to the U.S. Food
and Drug Administration for ARC-520, it’s drug candidate for the
treatment of chronic hepatitis B virus (HBV) infection. Arrowhead plans
to submit additional clinical trial authorization applications with
regulatory authorities in various jurisdictions in Europe and Asia.
Pending national regulatory review and approval, Arrowhead intends to
initiate two Phase 2b, multicenter, randomized, double-blind,
placebo-controlled, multi-dose studies to determine the depth of
hepatitis B surface antigen (HBsAg) reduction following ARC-520
injection in combination with entecavir or tenofovir in patients with
chronic immune active HBV infection. The Heparc-2002 study is planned to
include patients who are negative for hepatitis B e-antigen (HBeAg) at
screening and the Heparc-2003 study is planned to include patients who
are positive for HBeAg at screening. The primary objective is to
evaluate the depth of HBsAg decline in response to multiple doses of
ARC-520 compared to placebo in patients with chronic HBV infection as a
measure of drug activity. Secondary objectives are to assess measures of
safety and tolerability and to evaluate multi-dose pharmacokinetics of
ARC-520 in patients with chronic HBV infection when co-administered with
a fixed dose of entecavir or tenofovir, in addition to other exploratory
safety and pharmacodynamic objectives.
“As with our recent application to begin a Phase 1 study with ARC-AAT,
this IND represents achievement of a key 2014 goal,” said Arrowhead
President and CEO, Dr. Christopher Anzalone. “We look forward to
beginning multi-dose studies with ARC-520.”
About ARC-520
Arrowhead’s RNAi-based candidate ARC-520 is being investigated in the
treatment of chronic HBV infection. The small interfering RNAs (siRNAs)
in ARC-520 intervene at the mRNA level, upstream of the reverse
transcription process where current standard of care nucleotide and
nucleoside analogues act. Arrowhead is investigating ARC-520
specifically, to determine if it can be used to achieve a functional
cure, which is an immune clearant state characterized by hepatitis B
s-antigen negative serum with or without sero-conversion. Arrowhead has
completed a Phase 1 single ascending dose study in normal volunteers and
the company is conducting a single dose Phase 2a study in chronic HBV
patients. Approximately 350-400 million people worldwide are chronically
infected with the hepatitis B virus, which can lead to cirrhosis of the
liver and is responsible for 80% of primary liver cancers globally.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing
targeted RNAi therapeutics. The company is leveraging its proprietary
Dynamic Polyconjugate™ delivery platform to develop targeted drugs based
on the RNA interference mechanism that efficiently silences
disease-causing genes. Arrowhead’s pipeline includes ARC-520 for chronic
hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1
antitrypsin deficiency, and partner-based programs in obesity and
oncology.
For more information please visit http://www.arrowheadresearch.com,
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Source: Arrowhead Research Corporation
Arrowhead Research Corporation
Vince Anzalone, CFA, 626-304-3400
ir@arrowres.com
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Source: Arrowhead Research Corporation
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