–SER-109 met Phase 3 primary endpoint,
showing a highly statistically significant 30.2% absolute reduction
in the rate of C. difficile infection recurrence compared to
placebo –
–SER-109 was well tolerated, with a
safety profile comparable to placebo –
– Efficacy results substantially
exceeded FDA regulatory guidance to support BLA filing as a single
pivotal trial; Company to meet with agency to discuss filing for
product approval as soon as possible –
– Positive SER-109 Phase 3 data provide
validation for Seres’ microbiome therapeutics platform and further
development of its pipeline of product candidates –
– Conference call at 8:30 a.m. ET today
–
Seres Therapeutics, Inc. (Nasdaq: MCRB) today reported positive
topline results from the pivotal Phase 3 ECOSPOR III study
evaluating its investigational oral microbiome therapeutic SER-109
for recurrent C. difficile infection (CDI). The study showed that
SER-109 administration resulted in a highly statistically
significant absolute decrease of 30.2% in the proportion of
patients who experienced a recurrence in CDI within eight weeks of
administration versus placebo, the study’s primary endpoint. 11.1%
of patients administered SER-109 experienced a CDI recurrence,
versus 41.3% of placebo patients. The study results were equally
compelling when characterized by the alternative metric of
sustained clinical response, where 88.9% of patients in the SER-109
arm achieved this objective.
The study’s efficacy results exceeded the statistical threshold
previously provided in consultation with the U.S. Food and Drug
Administration (FDA) that could allow this single clinical study to
fulfill efficacy requirements for a Biologics License Application
(BLA). The SER-109 safety results were favorable, with an adverse
event profile comparable to placebo.
“We are extremely pleased with these highly clinically
meaningful SER-109 Phase 3 study results, greatly exceeding the
statistical threshold provided by the FDA. Based on our prior
discussions with the FDA, we believe this trial should provide the
efficacy basis for submitting an application for product approval.
We look forward to meeting with the FDA as soon as possible to
discuss the regulatory path forward with the goal of bringing
SER-109 to patients as a first-in-class microbiome therapeutic,”
said Eric D. Shaff, President and Chief Executive Officer of Seres.
“Our results represent the first-ever positive pivotal clinical
study results for a targeted microbiome drug candidate. We believe
these Phase 3 data provide strong validation for our underlying
microbiome therapeutics platform, which has been the scientific
basis for the Company, as well as persuasive clinical evidence
supporting our other active pipeline programs.”
“We would like to thank all those who participated in this
landmark study. Based on these highly positive SER-109 ECOSPOR III
results, we believe that this novel microbiome therapeutic
candidate could potentially provide a much-needed effective oral
treatment option for the approximately 170,000 patients in the U.S.
that suffer from recurrent CDI annually,” said Lisa von Moltke,
M.D., FCP, Chief Medical Officer of Seres. “Seres applied a
data-driven and scientifically rigorous approach to develop
SER-109. The proprietary scientific learnings we have obtained
continue to drive our overall R&D efforts and the advancement
of our other ongoing microbiome therapeutic programs.”
“Recurrent C. difficile infection is a serious disease that
devastates patients’ quality of life, and in many severe cases may
result in a patient’s death. Today’s treatment options have
important shortcomings related to efficacy, safety and route of
administration, and novel approaches that target the root causes of
the disease are urgently needed. The SER-109 Phase 3 results are
highly impressive and represent an exceptional advance in the fight
against this disease. I believe that SER-109 has the potential to
fundamentally transform the treatment of recurrent C. difficile
infection,” said Mark Wilcox, M.D., Professor of Medical
Microbiology, University of Leeds.
ECOSPOR III Study Design and Results
The ECOSPOR III study (ClinicalTrials.gov identifier:
NCT03183128) is a multicenter, randomized, placebo-controlled study
that enrolled 182 patients with multiply recurrent CDI. Patients
were randomized 1:1 to receive either SER-109 or placebo, after
standard of care antibiotic treatment. SER-109, or placebo, was
administered orally for three consecutive days. All patients were
required to have a positive C. difficile toxin diagnostic test both
at study entry and in the case of suspected recurrence to ensure
the selection of individuals with active disease and to confirm the
accuracy of the primary endpoint.
The primary efficacy endpoint of ECOSPOR III was the proportion
of patients with recurrent CDI at up to eight weeks following
administration of SER-109 or placebo. As a secondary endpoint,
patients are evaluated for CDI recurrence through 24 weeks
post-treatment, and the Company plans to present those results at a
future date.
SER-109 met the study’s primary endpoint with a significantly
lower recurrence rate of 11.1% in SER-109 patients versus 41.3% in
placebo patients at eight weeks; p<0.001 tested at the one-sided
0.25 level. Patients administered SER-109 experienced a 30.2% lower
rate of recurrence, on an absolute basis, compared to placebo. The
SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51)
versus placebo. The ECOSPOR III recurrence rates translate into a
sustained clinical response rate of 88.9% versus 58.7% with SER-109
and placebo, respectively. The SER-109 Number Needed to Treat (NNT)
was approximately 3.
In prior discussions, the FDA communicated that demonstration of
a statistically very persuasive efficacy finding in the ECOSPOR III
primary endpoint, defined as demonstrating a 95% upper confidence
level of relative risk lower than 0.833, could support a BLA
submission on the basis of this single study. The results of
ECOSPOR III demonstrated a SER-109 relative risk of 0.27 (95%
CI=0.15 to 0.51) compared to placebo. As a result, Seres believes
that this study should support the efficacy basis for BLA
submission. SER-109 has obtained FDA Breakthrough Therapy and
Orphan Drug designations.
SER-109 was well tolerated, with no treatment-related serious
adverse events (SAEs) observed in the active arm, and an adverse
event profile similar to placebo. The overall incidence of patients
who experienced AEs during the eight-week study period was similar
between SER-109 and placebo arms. The most commonly observed
treatment-related AEs were flatulence, abdominal distention and
abdominal pain, which were generally mild to moderate in nature,
and these were observed at a similar rate in both the SER-109 and
placebo arms.
A SER-109 open-label study is ongoing (ClinicalTrials.gov
identifier: NCT03183141) at selected clinical sites that
participated in the ECOSPOR III study, and the Company may initiate
the program at additional clinical sites. The FDA has previously
indicated that SER-109 administration to at least 300 patients,
consistent with standard FDA guidance, would be required to support
BLA submission. The ongoing SER-109 open-label study is continuing
to contribute to the SER-109 safety database.
The Company plans to immediately request a Breakthrough Therapy
designation meeting with the FDA to discuss the requirements to
submit a BLA seeking regulatory approval of SER-109. Given the
favorable efficacy and safety results seen in ECOSPOR III, the
safety results observed in prior SER-109 clinical studies, and the
critical unmet need for a therapeutic option for recurrent CDI
patients, the Company plans to discuss with the FDA the safety data
requirements for a BLA filing.
Seres continues to advance its commercial readiness for the
potential launch of SER-109. In June 2020, Seres appointed Terri
Young, Ph.D., R.Ph., as Chief Commercial and Strategy Officer. The
Company has been conducting activities to support successful future
potential commercialization. Seres believes that the commercial
opportunity for SER-109 could be substantial, given the dire need
for an effective, safe, oral therapeutic, and the strength of the
SER-109 Phase 3 study results.
Conference Call Information
Seres’ management will host a conference call today, August 10,
2020, at 8:30 a.m. ET. To access the conference call, please dial
844-277-9450 (domestic) or 336-525-7139 (international) and
reference the conference ID number 3216859. Accompanying slides
will be posted on the Seres website ahead of the conference call.
To join the live webcast, and to view the accompanying slides,
please visit the “Investors and Media” section of the Seres website
at www.serestherapeutics.com.
A webcast replay will be available on the Seres website
beginning approximately two hours after the event and will be
archived for approximately 21 days.
About SER-109
SER-109 is an investigational, oral, biologically-derived
microbiome therapeutic that is designed to reduce recurrence of C.
difficile infection (CDI), enabling patients to achieve a sustained
clinical response by breaking the vicious cycle of CDI recurrence
and restoring the diversity of the gastrointestinal microbiome.
SER-109 is a consortium of purified bacterial spores of multiple
Firmicute species, manufactured by fractionating targeted bacteria
from the stool of healthy human donors with further steps to
inactivate potential pathogens. The FDA has granted SER-109
Breakthrough Therapy designation and Orphan Drug designation for
the treatment of CDI.
SER-109 is fundamentally distinct from fecal microbiota
transplantation (FMT). SER-109 is comprised of a highly-purified
consortia of spore-based commensal bacteria and designed to be
manufactured in accordance with Good Manufacturing Practice
conditions using stringent standards to ensure product quality and
consistency. To support product safety, Seres utilizes a unique
manufacturing process that inactivates numerous potential
pathogens, including species of non-spore bacteria, such as
Escherichia coli, and viruses such as SARS-CoV-2.
About C. difficile Infection (CDI) and Current
Treatments
C. difficile infection (CDI) is one of the top three most urgent
antibiotic-resistant bacterial threats in the U.S., according to
the Centers for Disease Control, and is a leading cause of
hospital-acquired infection in the U.S. It is responsible for the
deaths of approximately 20,000 Americans each year. CDI is
associated with debilitating diarrhea, which significantly impacts
quality of life in every functional domain. Since the discovery of
C. difficile more than four decades ago, vancomycin has been the
most commonly used drug for patient management. Current approaches
provide only modest improvements in sustained clinical response
rates, leaving behind a significant pool of patients with recurrent
disease. Unapproved FMT, used in cases that are not responsive to
approved drugs, remains poorly characterized clinically and has
been associated with serious safety concerns, including the
transmission of bacterial pathogens and the potential transmission
of viruses such as SARS-CoV-2, the virus that causes COVID-19. The
recent quarantine and shipping hold of FMT from a major stool bank
highlights the urgent need for an approved effective and safe
treatment for recurrent CDI.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome
therapeutics platform company developing a novel class of
multifunctional bacterial consortia that are designed to
functionally interact with host cells and tissues to treat disease.
Seres’ SER-109 program achieved the first-ever positive pivotal
clinical results for a targeted microbiome drug candidate and has
obtained Breakthrough Therapy and Orphan Drug designations from the
FDA. The SER-109 program is being advanced for the treatment of
recurrent C. difficile infection and has potential to become a
first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287
program has obtained Fast Track and Orphan Drug designations from
the FDA and is being evaluated in a Phase 2b study in patients with
active mild-to-moderate ulcerative colitis. Seres is developing
SER-401 in a Phase 1b study in patients with metastatic melanoma,
SER-301 for ulcerative colitis and SER-155 to prevent mortality due
to gastrointestinal infections, bacteremia and graft versus host
disease. For more information, please visit
www.serestherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including the potential approval of
SER-109 by the FDA, the potential for SER-109 to be a
first-in-class therapy, the timing, content and outcome of any
meetings with the FDA, the results from ECOSPOR III providing an
efficacy basis for a BLA submission, the potential number of
patients who could be treated by SER-109, the ability of SER-109 to
transform the treatment of CDI or be a much-needed effective oral
treatment option for recurrent CDI, the potential requirements by
the FDA for additional safety data, initiation of additional
clinical sites in the open-label study of SER-109, commercial
opportunity of SER-109, the impact of SER-109 data on the Seres
pipeline programs and platform overall, the design of SER-109 and
its treatment potential, and the presentation of ECOSPOR III
24-week data, and other statements that are not historical
facts.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: We have incurred significant losses, are not currently
profitable and may never become profitable; our need for additional
funding; our limited operating history; our unproven approach to
therapeutic intervention; the lengthy, expensive, and uncertain
process of clinical drug development; our reliance on third parties
to manufacture, develop, and commercialize our product candidates,
if approved; the ability to develop and commercialize our product
candidates, if approved; the potential impact of the COVID-19
pandemic; our ability to retain key personnel and to manage our
growth; and that our management and principal stockholders have the
ability to control or significantly influence our business. These
and other important factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission, or SEC, on July 28, 2020 and
our other reports filed with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
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