Spring Bank Pharmaceuticals Announces the Data Safety Monitoring Board Approves Dose Escalation of SB 9200 for the Second Coh...
May 15 2017 - 8:00AM
Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of viral infections, cancer, and inflammatory diseases,
announced today that the Data Safety Monitoring Board (DSMB), an
independent group of medical experts closely monitoring Spring
Bank’s ACHIEVE global Phase 2a clinical trial evaluating SB 9200 in
treatment-naïve chronic Hepatitis B virus (HBV) patients without
cirrhosis, has reviewed the initial safety and tolerability data
from the 25mg monotherapy dose cohort (n=20) in the Phase 2a
clinical trial of SB 9200. Based on their assessment of the safety
data, the DSMB approved proceeding with the enrollment for the
second cohort of the Phase 2a segment of the ACHIEVE trial with a
dose escalation to 50mg once a day.
Spring Bank also announced that study
investigators have already begun screening patients for the second
cohort of the ACHIEVE trial, which will also enroll 20
patients.
“We are encouraged that SB 9200 appeared to be
well-tolerated based on the DSMB’s assessment of the data from the
first cohort and their authorization to proceed with the second
monotherapy dosing cohort,” stated Nezam Afdhal, M.D., chief
medical officer of Spring Bank. “We look forward to continuing the
ACHIEVE trial and hope to rapidly enroll patients into the second
cohort of the Phase 2a segment of the trial.”
SB 9200 is a novel small molecule nucleic acid
hybrid (SMNH) compound being developed as both monotherapy and
combination therapy for the treatment of chronic HBV. The
first segment of the ACHIEVE trial is a Phase 2a
placebo-controlled, sequential-cohort, double-blind trial to
evaluate increasing doses of SB 9200 as monotherapy for 12 weeks
followed by tenofovir disoproxil fumarate (marketed by Gilead
Sciences, Inc. as Viread®) 300 mg for an additional 12 weeks.
The Phase 2a segment of the ACHIEVE trial has an adaptive trial
design that will enroll 80 chronically-infected HBV patients
between 18 and 70 years of age who have been or will be assigned to
one of four dosing cohorts, 25 mg, 50 mg, 100 mg or 200 mg of SB
9200, or placebo, once daily for 12 weeks. All subjects will then
receive Viread 300 mg once daily for an additional 12 weeks of
treatment. The Phase 2b segment of the ACHIEVE trial is designed to
examine the concomitant use of SB 9200 and Viread in approximately
200 HBV patients.
Spring Bank anticipates reporting top-line
results from the 25mg monotherapy dosing cohort of the ACHIEVE
trial in the coming weeks.
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 (SMNH) chemistry platform. SMNH
compounds are small segments of nucleic acids that the company
designs to selectively target and modulate the activity of specific
proteins implicated in various disease states. The company is
developing its most advanced SMNH product candidate, SB 9200, for
the treatment of viral diseases, including hepatitis B virus (HBV).
SB 9200 has been designed to selectively activate within infected
cells the cellular proteins, retinoic acid-inducible gene 1, or
RIG-I, and nucleotide-binding oligomerization domain-containing
protein 2, or NOD2, which have been implicated in the body's immune
response to viral infections. Spring Bank Pharmaceuticals is also
developing other SMNH product candidates, including SB 11285,
the company’s lead immunotherapeutic agent for the treatment of
selected cancers through the activation of the STimulator of
INterferon Genes, or STING, pathway. For more information, please
visit www.springbankpharm.com.
Forward-Looking Statements
Any statements in this press release about
Spring Bank’s future expectations, plans and prospects, including,
but not limited to, statements about the company’s anticipated
timeline for disclosing top-line results from the first SB 9200
monotherapy dosing cohort in the Phase 2a trial of SB 9200 and
expectations and hopes for the enrollment of patients in the second
cohort of the Phase 2a segment of the ACHIEVE trial, as well as any
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 and/or trials anticipated; whether results obtained in
preclinical studies and 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, or at all; 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 any
product candidates obtain approval, they will be successfully
distributed and marketed; and other factors discussed in the "Risk
Factors" section of Spring Bank’s Annual Report on Form 10-K for
the year ended December 31, 2016, which was filed with the
Securities and Exchange Commission (SEC) on February 14, 2017, 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.
Contact:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
jfreve@springbankpharm.com
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