Arrowhead Receives Regulatory Clearance to Begin Additional Phase 2b Studies of Hepatitis B Candidate ARC-520
June 17 2015 - 7:30AM
Business Wire
Arrowhead Research Corporation (NASDAQ: ARWR), a
biopharmaceutical company developing targeted RNAi therapeutics,
today announced that its Clinical Trial Application for ARC-520,
its clinical candidate for chronic hepatitis B infection (HBV), has
been approved by Germany’s Federal Institute for Drugs and Medical
Devices. The company now has regulatory clearance in Germany for
two additional Phase 2b multiple-dose studies of ARC-520 to be
conducted in parallel. Arrowhead awaits final IRB approval from the
sites, which are expected shortly, and in addition, the company is
engaged with regulatory authorities from Hong Kong and South Korea
to open additional sites for these studies. Arrowhead will provide
guidance in the future on timing for release of data from these
studies.
"ARC-520 is leading the way in studying the use of RNAi drugs as
new treatment options for chronic HBV. We are very pleased to
receive regulatory clearance in Europe to conduct the parallel
design Phase 2b multiple-dose studies that we proposed,” said Bruce
D. Given, M.D., Arrowhead’s Chief Operating Officer. “We view these
studies as the front end of a set of global multiple-dose studies
designed to identify the right agents, doses, and regimens that can
achieve functional cures. Based on multiple-dose data from our
recently disclosed chimpanzee study and the long duration of
activity ARC-520 has demonstrated in the single-dose Phase 2a study
in patients, we are starting with doses of 1mg/kg and 2mg/kg in
parallel. We have incorporated an interim analysis in both studies
to get an early read on whether we may want to interrogate higher
doses. ARC-520 continues to be well tolerated and we have not seen
any signal suggesting that we are approaching a maximum tolerated
dose through 4mg/kg, the highest dose studied in humans to
date.”
The studies titled Heparc-2002 and Heparc-2003 will enroll
patients with chronic HBV infection that are e-antigen (HBeAg)
negative and HBeAg positive, respectively. Each study is a
multicenter, randomized, double-blind, placebo-controlled,
multi-dose study intended to evaluate two dose levels in parallel
of ARC-520 in combination with entecavir or tenofovir in patients
with immune active chronic HBV infection. The 2002 and 2003 studies
are planned to enroll up to 60 and 90 patients, respectively. In
each study, patients will be randomized to receive four doses, once
every 4 weeks, of either 1 mg/kg ARC-520, 2 mg/kg ARC-520, or
placebo at a ratio of 1:1:1.
For each patient, the duration of the study is approximately 33
weeks, from screening to the Day 169 follow-up visit. For each
study, a planning interim analysis will be performed when 54
patients have completed their Day 71 visit. This analysis will be
used to plan future studies only and will not impact the enrollment
or conduct of Heparc-2002 and -2003. Based on the interim results,
the company will decide whether higher multiple-doses would be
likely to lead to increased activity, in which case higher doses
may be evaluated in one or more additional studies.
The primary objective of the 2002 and 2003 studies is to
evaluate the depth of hepatitis B surface antigen (HBsAg) decline
in response to multiple doses of ARC-520 compared to placebo as a
measure of drug activity. Secondary objectives include the
assessment of safety and tolerability and multi-dose
pharmacokinetics of ARC-520 when co-administered with entecavir or
tenofovir, in addition to other exploratory objectives.
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
single dose Phase 2a studies and multiple dose Phase 2b studies 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 and ARC-AAT for
liver disease associated with Alpha-1 antitrypsin deficiency.
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, 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.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Research Corporation.
Source: Arrowhead Research Corporation
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version on businesswire.com: http://www.businesswire.com/news/home/20150617005443/en/
Contacts:Arrowhead Research CorporationVince Anzalone,
CFA626-304-3400ir@arrowres.comorInvestor Relations:The Trout
GroupTodd James646-378-2926ir@arrowres.comorMedia:Russo
PartnersMatt Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.com
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