Seres Therapeutics Initiates SER-109 Phase 3 Study in Patients with Multiply Recurrent C. difficile Infection
- Based on recent
- SER-109 Phase 3 Trial is the first pivotal trial in the emerging field of microbiome-based oral therapeutics -
- Phase 3 Trial initiation triggers a
“We are extremely pleased to be able to initiate the SER-109 Phase 3
ECOSPOR III study. If ECOSPOR III is successful, we believe this study
could serve as the basis for SER-109 approval. Our goal is to have
SER-109 approved as the first microbiome drug in this new field of
medicine, and the first for patients with multiply recurrent C.
difficile infection, an area of very high unmet need for patients in
the U.S. and around the world,” said
The ECOSPOR III Phase 3 study design incorporates direct learnings from
prior SER-109 development efforts, as well as helpful feedback obtained
from the
The initiation of the SER-109 Phase 3 ECOSPOR III study triggers a
About SER-109 and C. difficile Infection
SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome
therapeutic for the treatment of multiply recurrent C. difficile
infection. SER-109 is a biologically sourced consortium of bacterial
spores designed to catalyze a shift in a dysbiotic gastrointestinal
microbiome to a healthier state. The
C. difficile infection is one of the top three most urgent
antibiotic-resistant bacterial threats in
About Seres Therapeutics
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, which may not be available;
our limited operating history; the unpredictable nature of our early
stage development efforts for marketable drugs; the unproven approach to
therapeutic intervention of our microbiome therapeutics; the lengthy and
expensive process of clinical drug development, which has an uncertain
outcome; potential delays in enrollment of patients which could affect
the receipt of necessary regulatory approvals; potential delays in
regulatory approval, which would impact the ability to commercialize our
product candidates and affect our ability to generate revenue; any fast
track or Breakthrough Therapy designation may not lead to faster
development, regulatory approval or marketing approval; our possible
inability to receive orphan drug designation should we choose to seek
it; our reliance on third parties to conduct our clinical trials and the
potential for those third parties to not perform satisfactorily; our
reliance on third parties to manufacture our product candidates, which
may delay, prevent or impair our development and commercialization
efforts; our lack of experience in manufacturing our product candidates;
the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling,
marketing and distributing products and our lack of internal capability
to do so; failure to compete successfully against other drug companies;
potential competition from biosimilars; failure to obtain marketing
approval internationally; post-marketing restrictions or withdrawal from
the market; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently
enacted or future legislation; compliance with environmental, health,
and safety laws and regulations; protection of our proprietary
technology; protection of the confidentiality of our trade secrets;
changes in
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Source:
IR or PR Contact:
Seres
Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor
Relations and Corporate Communications
Ctanzi@serestherapeutics.com