Seres Therapeutics Reports SER-287 Phase 1b Microbiome Analyses that Provide Mechanistic Support for Clinical Efficacy in Ulcerative Colitis
- Microbiome analyses demonstrate engraftment of SER-287-derived bacteria; microbiome compositional changes correlate with clinical remission -
- SER-287 engraftment maintained four weeks after completion of dosing -
- Company to discuss proposed SER-287 development plan with
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- Additional results to be presented at a Webcast 2018
“These microbiome data provide Seres with important proprietary insights
into the mechanisms of action of SER-287 in Ulcerative Colitis and
inform the study design of our next SER-287 clinical trial. The SER-287
bacterial signatures identified in humans also provide indispensable
clinical insights towards optimizing the composition of SER-301, a
rationally designed microbiome therapeutic candidate for UC and other
forms of inflammatory bowel disease,” said
SER-287 Phase 1b study design, summary of previously reported clinical results
As reported in
Seres used stool samples and whole metagenomic sequencing analyses that enable species-level resolution analyses to characterize changes in the gastrointestinal microbiome.
Microbiome study results
Microbiome results demonstrated engraftment of SER-287-derived bacterial species in patients pre-treated with vancomycin who received SER-287. The degree of SER-287 engraftment, as measured by the number of detectable SER-287-derived bacterial species, increased in a dose-dependent manner, with daily dosing providing the most rapid and robust change in patients’ microbiome. Engraftment was maintained during the entire dosing period and was observed four weeks after the last dose of SER-287 was administered. Thus, engraftment was durable. Changes in the composition of the gastrointestinal microbiome were associated with clinical remission.
Vancomycin pre-treatment, as compared to placebo pre-treatment, led to an immediate reduction of microbiome diversity followed by rapid and robust engraftment of SER-287-derived bacterial species. These data suggest that vancomycin pre-treatment opens ecological niches for SER-287 engraftment in the human microbiome of patients with UC.
Seres intends to present additional study data in a webcast company
presentation at the 2018
About SER-287
SER‐287 is a biologically sourced, oral formulation containing a
consortium of live bacterial spores that is being developed for
Ulcerative Colitis and other forms of inflammatory bowel disease. The
About Ulcerative Colitis
Ulcerative Colitis (UC) is a serious chronic condition affecting
approximately 700,000 individuals in the
About Seres Therapeutics
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 release of further
data, the potential for SER-287 to treat UC patients, including
pediatric UC patients, the timing of discussions with the
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, including
potential delays in regulatory approval; our reliance on third parties
and collaborators to conduct our clinical trials, manufacture our
product candidates, and develop and commercialize our product
candidates, if approved; our lack of experience in manufacturing,
selling, marketing, and distributing our product candidates; orphan drug
designation may not lead to faster development; failure to compete
successfully against other drug companies; protection of our proprietary
technology and the confidentiality of our trade secrets; potential
lawsuits for, or claims of, infringement of third-party intellectual
property or challenges to the ownership of our intellectual property;
our patents being found invalid or unenforceable; risks associated with
international operations; our ability to retain key personnel and to
manage our growth; the potential volatility of our common stock; our
management and principal stockholders have the ability to control or
significantly influence our business; and we are currently subject to
securities class action litigation. These and other important factors
discussed under the caption “Risk Factors” in our Quarterly Report on
Form 10-Q filed with the
References
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Jairath V. et al., Systematic review and meta-analysis: placebo rates
in induction and maintenance trials in ulcerative colitis;
Journal of Crohn's and Colitis , 2016 -
Blander JM et al., Regulation of inflammation by microbiota
interactions with the host, Nature Immunology, 2017; Lynch S and
Pedersen O, The Human Intestinal Microbiome in Health and Disease,
The New England Journal of Medicine , 2016.
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Source:
Seres Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of
Investor Relations and Corporate Communications
ctanzi@serestherapeutics.com