- New data demonstrate a sustained patient
benefit following SER-109 administration with a highly
statistically significant 31.1% absolute reduction in the rate of
C. difficile infection recurrence over 12 weeks, compared to
placebo –
- Additional new findings show similar SER-109
efficacy across stratified age groups and prior antibiotic
treatment regimen cohorts –
- Well tolerated, with a safety profile
comparable to placebo –
- SER-109 open label study enrolling
individuals with recurrent C. difficile infection –
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced the
presentation of previously announced positive Phase 3 results from
the ECOSPOR III trial of SER-109 at the Virtual American College of
Gastroenterology (ACG) Annual Scientific Meeting taking place
October 23-28, 2020. New data to be presented in Seres’
late-breaker oral presentation show that SER-109 led to a sustained
highly statistically significant absolute reduction in C. difficile
infection recurrence at 12 weeks post-treatment when compared to
placebo. Additionally, new findings demonstrate that SER-109
administration resulted in similar efficacy when stratified by age
groups (i.e., > or <65 years) or prior antibiotic received
(i.e., vancomycin or fidaxomicin).
The ECOSPOR III study (ClinicalTrials.gov identifier:
NCT03183128) is a multicenter, randomized, placebo-controlled study
that enrolled 182 patients with multiply recurrent C. difficile
infection (CDI). Patients were randomized 1:1 to receive either
SER-109 or placebo, after standard of care antibiotic
treatment.
Previously reported topline data from ECOSPOR III showed that
SER-109 met the study’s primary endpoint with a 30.2% absolute
reduction of recurrence of CDI compared to placebo at 8 weeks
post-treatment.
New data show that at 12 weeks post-treatment the rate of
recurrence in the SER-109 arm was 16.7%, compared to a rate of
47.8% in the placebo arm, representing an absolute risk reduction
of 31.1% (relative risk 0.35; 95% CI 0.21-0.58; p-value <0.001),
consistent with the results seen at eight weeks.
“These new SER-109 Phase 3 data extend the dramatic topline
findings previously reported. The results demonstrate the
remarkable efficacy levels are sustained over a twelve-week period,
and similar treatment benefits are seen in both younger and older
patients. In addition, the data show consistent patient benefits
regardless of the baseline antibiotic treatment,” said Bret
Lashner, M.D., FACG, Professor of Medicine, Cleveland Clinic.
“SER-109 has the potential to lead a paradigm shift in the clinical
management of patients suffering from recurrent C. difficile
infection.”
Seres is sponsoring an ongoing SER-109 open label study in
patients with recurrent CDI (ClinicalTrials.gov identifier:
NCT03183128). Please inquire for additional information at
serescdiffstudy.com.
Presentation details are shown below, and abstracts have been
made available by ACG on their ACG2020 conference website.
Title: “8- and 12-week Efficacy and
Safety Data from ECOSPOR-III a Phase 3 Double-blind,
Placebo-Controlled Randomized Trial of SER-109, an Investigational
Microbiome Therapeutic for the Treatment of Patients with Recurrent
Clostridioides difficile Infection (rCDI)”
Presenter: Bret Lashner, M.D., FACG,
Professor of Medicine, Cleveland Clinic
About SER-109
SER-109 is an investigational, oral, biologically-sourced
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 Firmicute bacteria in spore
form, 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 recurrent CDI.
SER-109 is fundamentally distinct from fecal microbiota
transplantation (FMT) and FMT-like products. SER-109 is comprised
of a highly purified consortia of commensal bacteria in spore form,
manufactured in accordance with Current Good Manufacturing Practice
(cGMP) conditions using stringent standards to ensure product
quality and consistency. To support product safety, Seres utilizes
a unique manufacturing process designed to inactivate 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
drug most commonly used 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 material 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 ability of SER-109 to
transform the treatment of CDI or be a much-needed effective oral
treatment option for recurrent CDI, inferences related to the
currently-observed efficacy and safety profile of SER-109, 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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version on businesswire.com: https://www.businesswire.com/news/home/20201012005201/en/
PR Contact Lisa Raffensperger
lisa@tenbridgecommunications.com IR Contact Carlo Tanzi,
Ph.D. ctanzi@serestherapeutics.com
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