Arrowhead and Spring Bank Announce Clinical Collaboration for ARC-520 and SB 9200 in Chronic Hepatitis B
PASADENA, Calif. & HOPKINTON, Mass.–(BUSINESS WIRE)–
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.
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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.
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Litigation Reform Act:
This news release contains forward-looking statements within the
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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, CFA
626-304-3400
ir@arrowheadpharma.com
or
Investor
Relations:
The Trout Group
Chad Rubin, 646-378-2947
ir@arrowheadpharma.com
or
Media:
Russo
Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
or
Spring
Bank Contacts:
Jon Freve
Chief Financial Officer
508-500-4956
jfreve@springbankpharm.com
Source: Arrowhead Pharmaceuticals Inc.
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