Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT
April 09 2024 - 7:00AM
Business Wire
Clinical data readout expected end of Q3
2024
SER-155 and other Seres microbiome therapeutic
candidates have potential to expand microbiome therapeutic
franchise into additional medically vulnerable patient
populations
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome
therapeutics company, announced today that enrollment is complete
in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155
in patients who received Allogeneic Hematopoietic Stem Cell
Transplantation (Allo HSCT). SER-155 is an orally administered,
consortium of bacteria, cultivated from cell banks and designed to
reduce the incidence and severity of enteric-derived infections and
resulting bloodstream infections, including those that may harbor
antibiotic resistance. Infections are a leading cause of mortality
and morbidity in this immunocompromised patient population. SER-155
is also designed to induce immune tolerance responses to reduce the
incidence of GvHD.
“We are pleased to complete enrollment in Cohort 2 of our
SER-155 Phase 1b study and are looking forward to a robust dataset
late in the third quarter of this year,” said Eric Shaff, President
and Chief Executive Officer of Seres. “The initial study data will
include safety, drug pharmacology, and efficacy-related measures
through day 100 following HSCT, a period in which many patients
experience infections. There are an estimated 40,000 Allo HSCT
procedures annually worldwide and infection is one of the most
common causes of mortality in these patients. Our pending clinical
results could validate the promise of microbiome therapeutics to
prevent poor outcomes associated with pathogens in the GI tract. We
intend to evaluate SER-155 and other microbiome therapeutic
candidates in several other high prevalence, medically vulnerable
patient populations, including chronic liver disease, cancer
neutropenia, and solid organ transplants. We envision a future
where Seres is pioneering a new standard of care, potentially
protecting millions of immunocompromised patients from
life-threatening infections.”
The SER-155 Phase 1b study (NCT04995653) is being conducted
across 13 clinical centers in the US, including Memorial Sloan
Kettering. Study Cohort 1, which included 13 participants, was
designed to assess safety and drug pharmacology, including the
engraftment of drug bacteria in the gastrointestinal tract. Cohort
1 clinical data, announced in May 2023, showed favorable
tolerability, successful drug bacteria engraftment, and a
substantial reduction in pathogen domination in the
gastrointestinal microbiome. Study Cohort 2, which includes 45
participants, incorporates a randomized, double-blinded
placebo-controlled 1:1 design to further evaluate safety and
engraftment, as well as clinical outcomes.
About SER-155
SER-155 is a consortium of bacterial species selected using
Seres’ reverse translation discovery and development MbTx platform
technologies. The design incorporates microbiome biomarker data
from human clinical data and nonclinical human cell-based assays,
and in vivo disease models. The SER-155 composition is designed to
prevent and decrease the colonization and abundance of bacterial
pathogens that can harbor antibiotic resistance and to enhance
epithelial barrier integrity in the GI tract to both reduce the
likelihood of pathogen translocation and decrease the incidence of
bloodstream infections and GvHD. SER-155 has received FDA Fast
Track Designation.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage
company developing novel microbiome therapeutics for serious
diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval
in April 2023 as the first orally administered microbiome
therapeutic to prevent recurrence of C. difficile infection (CDI)
in adults following antibacterial treatment for recurrent CDI and
is being commercialized in collaboration with Nestlé Health
Science. Seres is evaluating SER-155 in a Phase 1b study in
patients receiving allogeneic hematopoietic stem cell
transplantation. 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 statements about the timing
and results of our clinical studies, the promise and potential
therapeutic impact of microbiome therapeutics, future product
candidates and development plans, and other statements which are
not historical fact.
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 novel approach to therapeutic intervention; our
reliance on third parties to conduct our clinical trials and
manufacture our product candidates; the competition we will face;
our ability to protect our intellectual property; and our ability
to retain key personnel and to manage our growth. These and other
important factors discussed under the caption “Risk Factors” in our
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC), on March 5, 2024, 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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