Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-520
PASADENA, Calif.–(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,
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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 Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
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Source: Arrowhead Research Corporation
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