Seres Therapeutics Announces Initiation of a Phase 1b Clinical Trial of SER-287 in Mild-to-Moderate Ulcerative Colitis
First Clinical Study of an Ecobiotic® Microbiome Therapeutic in a Chronic, Non-infectious Disease
“We are pleased to initiate this trial and advance our second microbiome
therapeutic candidate into the clinic. The development of SER-287 is
supported by a growing body of evidence suggesting that UC is marked by
an imbalance of bacteria (dysbiosis) in the gut, and that treating that
dysbiosis may lead to a meaningful clinical impact. SER-287 potentially
represents a novel and unique method to treat UC, and we are excited to
evaluate how SER-287 could be a significant development for patients in
need of more effective, non-immunosuppressive treatments for this very
difficult condition,” said
The randomized, placebo-controlled multiple dose Phase 1b study of
SER-287 is expected to enroll up to 55 subjects with active
mild-to-moderate UC who are failing current therapies. The primary
endpoint of the study will evaluate the change in the microbiome
resulting from SER-287 treatment. The study will also evaluate clinical
response, mucosal healing, as well as metabolomic, immunological and
safety findings. The study is being conducted in
The clinical development of SER-287 to treat UC is supported by preclinical studies in multiple animal models of colitis that provide evidence that SER-287 administration results in reduced pathology. Recently published clinical reports furthermore suggest that modulation of the microbiome through repetitive fecal microbiota transplants may lead to meaningful clinical response in certain UC patients.
SER-287 is an oral capsule developed using Seres’ proprietary microbiome therapeutics platform. It is a biologically sourced therapeutic candidate comprised of a complex and diverse bacterial spore ecology. In addition to SER-287, Seres’ development pipeline includes SER-301, a rationally designed, synthetic product comprised of in vitro cultured bacterial species for development in UC and other chronic gastrointestinal disorders with high unmet medical need.
About
About Ulcerative Colitis
Ulcerative colitis (UC) is a serious chronic condition affecting
approximately 700,000 individuals in
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 without limitation statements regarding the clinical benefit of SER-287, dysbiosis of the microbiome as an underlying cause of ulcerative colitis, the efficacy of treating the microbiome to treat ulcerative colitis, the enrollment of the Phase 1b clinical study for SER-287 and the timing of clinical study results.
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20151214005323/en/
Source:
IR Contact:
Seres Therapeutics
Carlo
Tanzi, Ph.D., 617-203-3467
Head of Investor Relations and Corporate
Communications
Ctanzi@serestherapeutics.com
or
PR
Contact:
Ten Bridge Communications
Dan Quinn,
781-475-7974
Dan@tenbridgecommunications.com