Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) and Spring Bank
Pharmaceuticals, Inc. (NASDAQ: SBPH), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of viral infections, cancer, and inflammatory diseases,
today announced an agreement to perform collaborative studies on
Arrowhead’s ARC-520 and Spring Bank’s SB 9200, for the treatment of
chronic Hepatitis B (HBV). The companies plan to first conduct
preclinical models with both agents together and then study the
agents clinically in a cohort to be added to Arrowhead’s ongoing
MONARCH Phase 2b study, in which patients will receive a dosing
regimen that includes ARC-520, SB 9200, and an oral direct-acting
antiviral.
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“The MONARCH Phase 2b combination study was specifically
designed to be iterative in nature, allowing us to seamlessly add
cohorts when additional novel agents are available to study in
combination with ARC-520,” said Bruce Given, M.D., chief operating
officer and head of R&D at Arrowhead. “We see ARC-520, which is
designed to silence the production of all HBV gene products, as a
potential backbone therapy for combinations. Spring Bank’s SB 9200
is a promising immunomodulatory agent with an interesting mechanism
that we think has significant therapeutic potential in combination
with ARC-520 and a NUC.”
“Our collaboration with our colleagues at Arrowhead
Pharmaceuticals will be the first study of two completely novel
agents in HBV, both focused on delivering a functional cure,” said
Nezam Afdhal, M.D., chief medical officer at Spring Bank
Pharmaceuticals. “We believe combining SB 9200 with Arrowhead’s
ARC-520, along with an approved nucleotide(side) polymerase
inhibitor, has the potential to lead to a functional cure.
Together, we hope to demonstrate in the MONARCH trial that triple
therapy can increase HBV functional cure rates with a more
favorable tolerability profile and perhaps a shorter duration of
treatment relative to current standard of care with
interferon-based regimens.”
About SB 9200
SB 9200 is Spring Bank’s novel small molecule, orally-available
selective immunomodulator compound being developed as both
monotherapy and combination therapy as a backbone for the treatment
of chronic HBV and other viral diseases. SB 9200 is currently being
studied in the ACHIEVE Phase II global trial. Part A of the ACHIEVE
study is a placebo-controlled, sequential cohort, double blind
trial to evaluate increasing doses of SB 9200 as monotherapy for 12
weeks followed by tenofovir disoproxil fumarate 300mg (Viread
Gilead Sciences Inc.) for a further 12 weeks. Part B of the ACHIEVE
study will evaluate SB 9200 in combination with tenofovir and as
monotherapy versus tenofovir monotherapy after the optimal doses of
SB 9200 are determined in Part A.
About ARC-520
Arrowhead’s ARC-520 is being investigated for its potential to
produce functional cures in patients with chronic hepatitis B virus
(HBV) infection. ARC-520 intervenes upstream of the reverse
transcription process where current standard-of-care nucleotide and
nucleoside analogs act, and is designed to silence the production
of all HBV gene products. The small interfering RNAs (siRNAs) in
ARC-520 engage the body’s normal cellular RNAi machinery and direct
specific cleavage of HBV RNA transcripts, thereby reducing the
levels of HBV proteins and the RNA template used to produce viral
DNA. Arrowhead is investigating ARC-520 specifically to determine
if significantly reducing circulating and non-circulating viral
proteins and RNA will allow for re-constitution of an effective
host immune response and ultimately HBsAg seroclearance resulting
in functional cure. As many as 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. Arrowhead is currently conducting Phase 2b
multiple dose and combination studies in chronic HBV patients. In
clinical studies to date, the most common reported adverse events
in all subjects completing treatment were upper respiratory
infection and headache.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat
intractable diseases by silencing the genes that cause them. Using
a broad portfolio of RNA chemistries and efficient modes of
delivery, Arrowhead therapies trigger the RNA interference
mechanism to induce rapid, deep, and durable knockdown of target
genes. RNA interference, or RNAi, is a mechanism present in living
cells that inhibits the expression of a specific gene, thereby
affecting the production of a specific protein. Arrowhead’s
RNAi-based therapeutics leverage this natural pathway of gene
silencing. The company’s pipeline includes ARC-520 and ARC-521 for
chronic hepatitis B virus infection, ARC-AAT for liver disease
associated with alpha-1 antitrypsin deficiency, ARC-F12 for
hereditary angioedema and thromboembolic disorders, ARC-LPA for
cardiovascular disease, and ARC-HIF2 for renal cell carcinoma.
For more information please visit www.arrowheadpharma.com, or
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DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Pharmaceuticals, Inc.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical-stage
biopharmaceutical company engaged in the discovery and development
of a novel class of therapeutics using its proprietary small
molecule nucleic acid hybrid, or SMNH, chemistry platform. The
company is developing its most advanced SMNH product candidate, SB
9200, for the treatment of viral diseases, including hepatitis B
virus.
Arrowhead 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. Our 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.
Spring Bank Safe Harbor Statement:
Any statements in this press release about Spring Bank’s future
expectations, plans and prospects, including statements about
Spring Bank’s financial prospects, future operations and
sufficiency of funds for future operations, clinical development of
Spring Bank’s product candidates, expectations regarding future
clinical trials and future expectations and plans and prospects for
Spring Bank and other statements containing the words "believes,"
"anticipates," "estimates," "expects," "intends," "plans,"
"predicts," "projects," "targets," "may," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
whether Spring Bank’s cash resources will be sufficient to fund its
continuing operations for the periods anticipated; whether results
obtained in clinical trials will be indicative of results obtained
in future clinical trials; whether Spring Bank’s product candidates
will advance through the clinical trial process on a timely basis;
whether the results of such trials will warrant submission for
approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether Spring Bank’s
product candidates will receive approval from regulatory agencies
on a timely basis or at all; whether, if product candidates obtain
approval, they will be successfully distributed and marketed; and
other factors discussed in the "Risk Factors" section of Spring
Bank’s quarterly report on Form 10-Q for the quarter ended
June 30, 2016, which is on file with the SEC, and in other
filings Spring Bank makes with the SEC from time to time. In
addition, the forward-looking statements included in this press
release represent Spring Bank’s views as of the date hereof. Spring
Bank anticipates that subsequent events and developments will cause
Spring Bank’s views to change. However, while Spring Bank may elect
to update these forward-looking statements at some point in the
future, Spring Bank specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing Spring Bank’s views as of any date subsequent to the
date hereof.
Source: Arrowhead Pharmaceuticals, Inc.
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Arrowhead Contacts:Arrowhead Pharmaceuticals, Inc.Vince
Anzalone, CFA626-304-3400ir@arrowheadpharma.comorInvestor
Relations:The Trout GroupChad Rubin,
646-378-2947ir@arrowheadpharma.comorMedia:Russo PartnersMatt
Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.comorSpring Bank
Contacts:Jon FreveChief Financial
Officer508-500-4956jfreve@springbankpharm.com
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