Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-520
April 13 2015 - 7:30AM
Business Wire
Arrowhead Research Corporation (NASDAQ: ARWR), a
biopharmaceutical company developing targeted RNAi therapeutics,
today announced that the United States Food and Drug Administration
(FDA) informed the Company that it can proceed with a multiple-dose
Phase 2b clinical study of ARC-520, its clinical candidate for the
treatment of chronic hepatitis B infection, under an
investigational new drug (IND) application previously filed with
the FDA.
“This notification from the FDA allows us to begin a
multiple-dose Phase 2b study of ARC-520, and we are working
diligently to get treatment sites up and running. Our goal is to
gain site IRB approvals and perform site initiation visits to begin
recruiting and enrolling patients for this study in about a month,
” said Bruce Given, M.D., chief operating officer and head of
R&D for Arrowhead. “We are also working with various regulatory
agencies outside of the United States to initiate additional Phase
2b studies.”
The clinical study, titled Heparc-2004, is a multicenter,
randomized, double-blind, placebo-controlled, multi-dose study of
ARC-520 administered intravenously to patients with chronic immune
active HBV infection maintained on entecavir or tenofovir therapy.
The study is planned to enroll up to 12 patients who will be
randomized at a ratio of 2:1 with 8 patients receiving 1 mg/kg of
ARC-520 and 4 patients receiving placebo. Each patient will receive
3 total doses, once every 4 weeks. Patients will be followed
through Day 147.
The primary objective of Heparc-2004 is to evaluate the depth of
hepatitis B surface antigen (HBsAg) decline in response to multiple
doses of ARC-520 compared to placebo in patients with chronic,
immune active HBV infection as a measure of drug activity.
Secondary objectives are to measure safety and tolerability and
pharmacokinetics of ARC-520, and to evaluate the effect of ARC-520
on entecavir or tenofovir pharmacokinetics, in addition to other
exploratory safety and pharmacodynamic objectives.
In connection with an IND filed in December 2014, Arrowhead
proposed a parallel design multiple-dose Phase 2b study testing
doses of 2 mg/kg and 4 mg/kg simultaneously. In January 2015, the
FDA notified the Company that a partial clinical hold had been
placed on the program. In order to proceed with the proposed
parallel design study, the FDA requested that the Company provide
additional information including data from the single-dose Phase 2a
study in patients who receive 1-4 mg/kg ARC-520, data from an
ongoing multiple-dose non-clinical study, and data from Heparc-2004
which is now cleared to begin.
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, 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
directly, please visit
http://ir.arrowheadresearch.com/alerts.cfm.
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, challenges to the
validity of our intellectual property rights, 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,
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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