Arrowhead to Present ARC-520 Phase 2a Data in Late-Breaking Session at AASLD Liver Meeting® 2014
PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today announced that data
from the ongoing Phase 2a study of ARC-520, its RNAi therapeutic
candidate for the treatment of chronic hepatitis B (HBV) infection, will
be presented in the late-breaking poster session at the 2014 American
Association for the Study of Liver Diseases (AASLD) Liver Meeting being
held on November 7-11, 2014, in Boston. Arrowhead was also selected to
deliver a plenary presentation with new preclinical efficacy data on
ARC-AAT, its RNAi therapeutic candidate for the treatment of liver
disease associated with Alpha-1 antitrypsin deficiency. Additional
details including abstracts for both presentations can be found in The
Liver Meeting section of the AASLD website at http://www.aasld.org/livermeeting/Pages/default.aspx.
“ARC-520 represents a novel approach for the treatment of HBV with the
potential to achieve functional cures,” said Christopher Anzalone,
Ph.D., Arrowhead’s President and Chief Executive Officer. “Our ongoing
Phase 2a dose finding study is an important step, and in cohort 1 at a
dose of 1 mg/mg and cohort 2 at 2 mg/kg we saw a clear reduction in
HBsAg, the surface antigen of HBV. Data collection for HBsAg reduction
in cohort 3 at 3 mg/kg is still ongoing, however we are pleased to
report that all three dose levels have been well tolerated in patients.
These results give us great confidence as we move forward with designing
and initiating several upcoming Phase 2b studies of ARC-520 and the
ARC-AAT Phase 1 study.”
Arrowhead presentations can be attended during the following times:
9:15 a.m. EST, Nov. 10, Plenary Session, John B. Hynes Convention
Center, Auditorium – An oral presentation titled, “A
hepatocyte-targeted RNAi-based treatment for liver disease associated
with alpha-1 antitrypsin deficiency,” will be presented by Christine
Wooddell, Ph.D., Group Leader, Arrowhead Research, Madison, Wis.
8 a.m. to 5:30 p.m. EST, Nov. 10, Late-Breaking Poster Session, John
B. Hynes Convention Center, Hall C – A poster presentation titled, “Phase
II, dose ranging study of ARC-520, a siRNA-based therapeutic, in
patients with chronic hepatitis B virus infection,” will be
presented by Man-Fung Yuen, M.D., Ph.D., Chair of Gastroenterology and
Hepatology, and Li Shu Fan Medical Foundation Professor in Medicine, The
University of Hong Kong.
About ARC-520
Arrowhead’s RNAi-based candidate ARC-520 is designed to treat chronic
HBV infection by reducing the expression and release of new viral
particles and key viral proteins. The goal is to achieve a functional
cure, which is an immune clearant state characterized by hepatitis B
s-antigen negative serum with or without sero-conversion. The siRNAs in
ARC-520 intervene at the mRNA level, upstream of where nucleotide and
nucleoside analogues act. In transient and transgenic mouse models of
HBV infection, a single co-injection of Arrowhead’s Dynamic
Polyconjugate (DPC) delivery vehicle with cholesterol-conjugated siRNA
targeting HBV sequences resulted in multi-log knockdown of HBV RNA,
proteins and viral DNA with long duration of effect. Arrowhead has
completed enrollment in a Phase 1 single ascending dose study in normal
volunteers. The company is conducting a single dose Phase 2a study in
chronic HBV patients, and expects to follow with multi-dose,
multi-national Phase 2b studies. Approximately 350 million people
worldwide are chronically infected with the hepatitis B virus. Chronic
HBV infection can lead to cirrhosis of the liver and is responsible for
80% of primary liver cancers globally.
About ARC-AAT
Arrowhead has developed ARC-AAT for the treatment of liver disease
associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic
disease that severely damages the liver and lungs of affected
individuals. ARC-AAT employs a novel unlocked nucleobase analog (UNA)
containing RNAi molecule designed for systemic delivery using the
Dynamic Polyconjugate delivery system. ARC-AAT is highly effective at
knocking down the Alpha-1 antitrypsin (AAT) gene transcript and reducing
the hepatic production of mutant AAT (Z-AAT) protein. Reduction of
inflammatory Z-AAT protein, which has been clearly defined as the cause
of progressive liver disease in AATD patients, is important as it is
expected to halt the progression of liver disease and allow fibrotic
tissue repair. The Company plans to file an Investigational New Drug
(IND) or equivalent application for ARC-AAT in the fourth quarter of
2014 and commence clinical studies shortly thereafter.
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.
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Arrowhead Research Corporation
Vince Anzalone, CFA, 626-304-3400
ir@arrowres.com
or
Investor
Relations:
The Trout Group
Lauren Glaser, 646-378-2972
ir@arrowres.com
or
Media:
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Partners
Martina Schwarzkopf, Ph.D., 212-845-4292
martina.schwarzkopf@russopartnersllc.com
Source: Arrowhead Research Corporation
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