- 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 FDA and intends to initiate next clinical
trial in mid-2018 -
- FDA granted SER-287 Orphan Drug designation
for treatment of pediatric UC patients -
- Additional results to be presented at a
Webcast 2018 JP Morgan Healthcare conference presentation on
Thursday, Jan. 11 at 8:30 a.m. PT -
Seres Therapeutics, Inc., (NASDAQ:MCRB) today announced initial
microbiome results from its Phase 1b study of SER-287, a microbiome
therapeutic candidate derived from healthy individuals, in patients
with mild-to-moderate Ulcerative Colitis (UC) who were failing
current therapies. Analyses of study patients’ microbiome data, a
co-primary study endpoint of the trial, demonstrate that SER-287
induced dose-dependent engraftment of SER-287-derived bacterial
species into the colonic microbiome of the patients treated with
SER-287. Patients administered vancomycin pre-treatment followed by
daily administration of SER-287 had the highest level of SER-287
engraftment, which was statistically significant. This patient
cohort corresponded with the study arm where the most significant
clinical benefits were observed, including clinical remission and
endoscopic improvement. Differences in the composition of the
microbiome post treatment were also associated with clinical
remission. Bacterial engraftment signatures were durable throughout
the dosing period of the trial and were also observed at four weeks
post administration of the final SER-287 dose. The SER-287 Phase 1b
study microbiome data support the previously reported clinical
results.
“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 Roger J. Pomerantz, M.D., President, CEO and
Chairman of Seres. “We look forward to discussing the SER-287
clinical and microbiome data with the FDA as we move this program
forward in clinical development.”
SER-287 Phase 1b study design, summary of previously reported
clinical results
As reported in October 2017, Seres completed a successful Phase
1b study of SER-287 in patients with mild-to-moderate UC who were
failing current therapies. The SER-287 Phase 1b study, a
randomized, double-blinded, placebo-controlled, multiple-dose,
induction study, enrolled 58 patients with mild-to-moderate UC.
Patients were assigned to one of three SER-287 treatment arms or a
placebo arm for an eight-week treatment period. SER-287 arms
included a daily dosing arm with six days of oral vancomycin
pre-treatment, a weekly dosing arm without vancomycin
pre-treatment, and a weekly dosing arm with six days of oral
vancomycin pre-treatment. Clinical study results demonstrated that
SER-287 administration resulted in a dose-dependent improvement of
clinical remission rates and endoscopic results. High clinical
response placebo rates that were not differentiated from the
SER-287 treatment arms were observed. Clinical response is a
subjective endpoint and is prone to high variability, as previously
observed in several other UC trials of various drug types1. In the
most recent FDA regulatory guidance, clinical remission, and not
clinical response, is recommended as the primary endpoint in UC
registrational studies. The SER-287 Phase 1b safety and
tolerability profile observed was very favorable.
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 JP Morgan Healthcare Conference on
Thursday, Jan. 11 at 8:30 a.m. PT. A live audio webcast of the
presentation will be available under the “Investors and Media”
section of Seres’ website. A replay of the presentation will become
available approximately one hour after the event and will be
archived for 21 days.
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 FDA has designated SER-287 as an Orphan Drug for pediatric
Ulcerative Colitis. SER-287 is hypothesized to act through a novel
mechanism of action by modulating the dysbiotic microbiome,
reducing inflammation without immunosuppression effects. A healthy
microbiome has been shown to maintain the integrity of the colonic
barrier, reduce the signaling by pro-inflammatory molecules
produced by certain bacteria, and induce regulatory T cells in the
colon to modulate immune responses.2
About Ulcerative Colitis
Ulcerative Colitis (UC) is a serious chronic condition affecting
approximately 700,000 individuals in the United States. The
disease results in inflammation of the colon and rectum and can
cause debilitating symptoms, including abdominal pain, bowel
urgency, and diarrhea. Severe cases of UC may result in surgical
removal of the colon.
About Seres Therapeutics
Seres Therapeutics, Inc., is a leading microbiome therapeutics
platform company developing a novel class of biological drugs that
are designed to treat disease by restoring the function of a
dysbiotic microbiome, where the natural state of bacterial
diversity and function is imbalanced. Seres’ lead program, SER-109,
has obtained Breakthrough Therapy and Orphan Drug designations from
the U.S. Food and Drug Administration and is in Phase 3 development
for multiply recurrent C. difficile infection. Seres’ clinical
candidate SER-287 has successfully completed a Phase 1b study in
patients with mild-to-moderate Ulcerative Colitis and has obtained
Orphan Drug designation in pediatric UC. Seres is also developing
SER-262, the first-ever synthetic microbiome therapeutic candidate,
in a Phase 1b study in patients with primary C. difficile
infection.
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 FDA and the potential approval of SER-287, and
the overall development of SER-287.
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 Securities and Exchange Commission, or
SEC, on November 8, 2017 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.
References
- 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180104005427/en/
Seres TherapeuticsCarlo Tanzi, Ph.D., 617-203-3467Head of
Investor Relations and Corporate
Communicationsctanzi@serestherapeutics.com
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