Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients
December 15 2014 - 7:30AM
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, or follow us on Twitter
@ArrowRes. To be added to the Company's email list and receive news
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Safe Harbor Statement under the Private Securities Litigation
Reform Act:
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our
actual results may differ materially and adversely from those
expressed in any forward-looking statements as a result of various
factors and uncertainties, including our ability to finance our
operations, the future success of our scientific studies, our
ability to successfully develop drug candidates, the timing for
starting and completing clinical trials, actions of the U.S. Food
and Drug Administration (FDA) and similar global regulatory bodies,
rapid technological change in our markets, and the enforcement of
our intellectual property rights. Arrowhead Research Corporation's
most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q discuss some of the important risk factors
that may affect our business, results of operations and financial
condition. We assume no obligation to update or revise
forward-looking statements to reflect new events or
circumstances.
Source: Arrowhead Research Corporation
Arrowhead Research CorporationVince Anzalone, CFA,
626-304-3400ir@arrowres.comorInvestor Relations:The Trout
GroupLauren Glaser, 646-378-2972ir@arrowres.comorMedia:Russo
PartnersMartina Schwarzkopf, Ph.D.,
212-845-4292martina.schwarzkopf@russopartnersllc.com
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