SB 9200 Shows Favorable Safety Profile and
Significant Antiviral Activity Against HBV DNA and HBsAg with
Initial Low Dose Monotherapy of 25mg
Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH) announced today the
top-line results from the 25mg monotherapy cohort of the Phase 2a
segment of the ACHIEVE study, a global, placebo-controlled,
sequential-cohort, double-blind Phase 2 clinical trial, focused on
the safety and antiviral activity of the orally-administered
selective immunomodulator, SB 9200, in patients with chronic HBV.
The initial cohort of the Phase 2a trial enrolled twenty (20)
treatment-naïve chronic HBV patients without cirrhosis across
multiple sites in Canada, Hong Kong and Korea. Patients were
randomized on a 4:1 basis and received either SB 9200 25mg or
placebo daily for 12 weeks. The primary endpoints for the Phase 2a
trial are safety and antiviral activity, as measured by the change
in HBV DNA at week 12 from baseline, with multiple exploratory
secondary endpoints. All patients in this cohort have transitioned
to tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc.
as Viread®) 300mg daily for an additional 12 weeks.
“We are strongly encouraged by the safety
profile of SB 9200 seen in this initial cohort of the Phase 2a
trial and by the evidence of antiviral activity seen at the low
dose of 25mg daily, because we studied the substantially higher
doses of 200mg – 900mg daily for 7 days in our Phase 1 study in HCV
patients,” stated Nezam Afdhal, M.D., D.Sc., Chief Medical Officer
of Spring Bank Pharmaceuticals. “The results from the initial
cohort of the Phase 2a trial continue to support the development of
SB 9200 as a potential treatment for chronic HBV to achieve the
goal of a functional cure. We have begun to rapidly enroll
the second cohort (50 mg) of our Phase 2a trial and hope to report
top-line results in the fourth quarter of 2017.”
The initial cohort consisted of 11
HBeAg-positive and 9 HBeAg-negative patients, of which 80% were
genotype B/C, the most common Asian genotypes. The overall safety
profile of SB 9200 was favorable, and over the 12-week study, no
serious adverse events were observed. Treatment-emergent adverse
events ranged from mild to moderate in severity with no
interferon-like side effects and were comparable to patients on
placebo. There were no Grade 3 laboratory abnormalities, but
alanine aminotransferase (ALT) flares, defined as an increase in
ALT above 200 IU/ml, were observed in three patients. Two of these
ALT flares were viral flares identified in patients on placebo and
the other ALT flare was identified in one patient on SB 9200 at
week 4, which was associated with a reduction in HBV DNA of 2.26
log10 and a 1.01 log10 reduction in HBsAg consistent with a
beneficial immune flare. Study investigators did not observe any
increase in bilirubin or evidence of hepatic decompensation.
Overall, SB 9200 demonstrated a statistically
significant reduction in HBV DNA at week 12 (unpaired t-test 2.85,
p=0.01) compared to placebo, with a mean reduction of 0.6 log10
(range 0 to 1.87 log10) in the SB 9200 treatment group. For the
secondary endpoint of quantitative HBsAg reduction, 5 of 16
patients (31%) in the SB 9200 treatment group had a greater than
0.5 log10 reduction at any time point (range 0.52 to 1.01 log10),
compared to none in the placebo group.
The 7 HBeAg-negative patients in the SB 9200
treatment group had the greatest mean reduction in HBV DNA at 0.9
log10, and 3 of these 7 patients also had a greater than 0.5 log10
reduction in HBsAg.
Professor Stephen Locarnini, the Principal
Investigator of the Virology Core for the ACHIEVE trial and the
Head, Research & Molecular Development, Victorian Infectious
Diseases Reference Laboratory, stated, “Our virological studies
from the first cohort showed antiviral activity of SB 9200
involving a novel immune and possibly direct antiviral mechanism
targeting RIG-I, resulting in not only reduction in HBV DNA but
also in HBsAg and HBV pgRNA as a surrogate for reduction in
cccDNA.”
Detailed results from the Phase 2a segment of
the ACHIEVE study will be presented at a future medical
conference.
Conference Call
Spring Bank Pharmaceuticals will host a
conference call at 8:00 a.m. ET tomorrow, Wednesday, May 24, 2017,
to discuss top-line results of the initial cohort of the Phase 2a
segment of the ACHIEVE study. The conference call may be accessed
by dialing (866) 294-9216 for U.S. callers and (346) 406-0955 for
international callers five minutes prior to the start of the call
and providing the conference ID 27754723. Additionally, the live,
listen-only webcast of the conference call can be accessed by
visiting the Investors & Media section of the company’s website
at www.springbankpharm.com. A replay of the conference call will be
available following the call and may be accessed by visiting Spring
Bank’s website.
About SB 9200 and the ACHIEVE
Study
Spring Bank’s lead product candidate, 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 Phase 2a clinical trial is
designed to enable Spring Bank to select one or two doses to move
forward into a Phase 2b clinical trial and to obtain the necessary
dosing and safety data to study the combined use of SB 9200 and a
direct-acting antiviral. 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 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 planned to
examine the concomitant use of SB 9200 and Viread® in approximately
200 HBV patients. Subject to the results of the Phase 2a clinical
trial and obtaining additional funding, Spring Bank plans to
initiate the Phase 2b segment of the ACHIEVE trial in 2018.
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
Statements in this press release about Spring
Bank’s future expectations, plans and prospects, including, but not
limited to, statements about the company’s expectations for the
enrollment of patients in the second cohort of the Phase 2a segment
of the ACHIEVE trial; the company’s anticipated timeline for
disclosing top-line results from the second cohort of the Phase 2a
segment of the ACHIEVE trial and the company’s anticipated timeline
for initiating the Phase 2b segment of the ACHIEVE trial, as well
as any other statements regarding matters that are not historical
facts, may 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
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.
Source: Spring Bank Pharmaceuticals
Contact:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
jfreve@springbankpharm.com
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