Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results
September 11 2020 - 7:00AM
Business Wire
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced that it
has obtained correspondence from the Office of Vaccines Research
and Review of the U.S. Food and Drug Administration (FDA) regarding
the Company’s plans to submit a Biologics License Application (BLA)
to support product approval of SER-109 for recurrent C. difficile
infection (CDI). After obtaining highly statistically significant
topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI,
Seres requested a Breakthrough Therapy Designation meeting with the
FDA. In response to the meeting request, the FDA reaffirmed its
prior guidance regarding the efficacy requirements to support a
SER-109 BLA submission, which were exceeded by the recent positive
SER-109 Phase 3 study results, reaffirmed its prior guidance that
at least 300 patients will be required for the safety database, and
indicated there was not a reason for a meeting at this time.
Seres is using its SER-109 open-label study, which also admits
patients with a single recurrence of CDI as previously discussed
with the FDA, to expand the SER-109 safety database. Seres is
taking various measures to expedite open-label study enrollment,
including increasing the number of SER-109 clinical study sites
across the U.S. and Canada. Seres also anticipates that the
quarantine of material used for unapproved Fecal Microbiota
Transplantation (FMT) by a national provider will accelerate
SER-109 open-label study enrollment.
“Our SER-109 ECOSPOR III Phase 3 study results at eight weeks
demonstrated an impressive 30.2% absolute reduction in CDI
recurrence, an 88.9% SER-109 sustained clinical response, and a
highly favorable safety profile. We believe SER-109 has the
potential to transform the outcomes for patients living with
recurrent CDI. We are very pleased that the FDA has reaffirmed the
efficacy requirements for a BLA filing, and we expect that our
Phase 3 data will provide the efficacy basis for product approval,”
said Eric D. Shaff, President and Chief Executive Officer of Seres.
“Patients suffering from recurrent CDI have no attractive treatment
options today, and some resort to unapproved FMT, which is unproven
and is documented to transmit infectious diseases. There is an
urgent need for a new effective and safe therapeutic option for
this disease.”
Mr. Shaff continued: “Seres is committed to serving patients
with recurrent CDI, a devastating and often fatal disease, and we
are working expeditiously to bring SER-109 forward to patients in
need. Our team is diligently executing our open-label study,
activating many new clinical sites in the process, and we expect to
expand the SER-109 safety database so that we can file a BLA as
soon as possible. We also plan to seek continued FDA dialogue to
discuss a rapid path to product approval.”
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). SER-109 is comprised of a highly purified
consortia of commensal bacteria in spore form and designed to be
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 timing, content, and
outcome of any potential meetings with the FDA, the potential
approval of SER-109 by the FDA, the results from ECOSPOR III
providing an efficacy basis for a BLA submission, 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, the initiation
of additional clinical sites in the open-label study of SER-109,
the speed of patient enrollment in the open-label study, including
the potential impact from the quarantine of material used for FMT,
the development of an adequate safety database, 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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PR Contact Lisa Raffensperger
lisa@tenbridgecommunications.com
IR Contact Carlo Tanzi, Ph.D.
ctanzi@serestherapeutics.com
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