Seres Therapeutics Announces Completion of Enrollment for SER-287 Phase 1b Study in Patients with Ulcerative Colitis
- Study results expected in the second half of 2017 -
“The completion of enrollment in our SER-287 Phase 1b study marks an
important step towards our goal of developing a novel microbiome-based
approach to treat ulcerative colitis, a serious disease where many
patients are not well managed by currently available therapies,” said
Several encouraging proof-of-concept studies using repetitive fecal microbiota transplantation support the rationale for development of microbiome therapeutics in ulcerative colitis.1 The SER-287 Phase 1b study is a randomized, placebo-controlled, multiple-dose study in subjects with mild-to-moderate ulcerative colitis who are failing current therapies. The primary objectives of the study are to evaluate safety, tolerability and change in the microbiome at up to 8 weeks after dosing. Initial study results, including microbiome, clinical, and endoscopy data, are expected in the second half of 2017.
About SER-287
SER‐287 is a biologically sourced oral capsule developed using Seres’ proprietary microbiome therapeutics platform. The SER-287 Phase 1b study clinicaltrials.gov identifier is NCT02618187. In addition to SER-287, Seres’ pipeline in ulcerative colitis includes SER-301, a rationally designed, synthetic product comprised of in vitro cultured bacterial species for development in ulcerative colitis and other chronic gastrointestinal disorders with high unmet medical need.
About Ulcerative Colitis
Ulcerative colitis is a serious chronic condition affecting
approximately 700,000 individuals in
About
References
1. Moayyedi, P, et al., Gastroenterology. 2015; Paramsothy S. et al., The Lancet. 2017
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 development potential for SER-287, the timing and results of our clinical trials, and dysbiosis as an underlying cause of disease.
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 and PA Contact:
Carlo Tanzi,
Ph.D., Seres Therapeutics, 617-203-3467
Head of Investor Relations
and Corporate Communications
ctanzi@serestherapeutics.com