– SER-287 microbiome treatment resulted in a
dose-dependent benefit in clinical remission rates, and an
improvement in endoscopic scores –
– No clinically significant safety or
tolerability findings were observed –
– Company intends to rapidly advance SER-287 to
further development for Ulcerative Colitis –
– Conference call scheduled for 8 a.m. today
–
In the table following the sixth paragraph, the difference from
placebo under Clinical Response for Vancomycin/SER-287 Daily is
0.0% and the Placebo/SER-287 Weekly is -17.1% (not -17.1% and 0.0%,
respectively).
The corrected release reads:
SERES THERAPEUTICS REPORTS POSITIVE TOPLINE
RESULTS FROM SER-287 PHASE 1B STUDY IN PATIENTS WITH
ULCERATIVE COLITIS
– SER-287 microbiome treatment resulted in a
dose-dependent benefit in clinical remission rates, and an
improvement in endoscopic scores –
– No clinically significant safety or
tolerability findings were observed –
– Company intends to rapidly advance SER-287 to
further development for Ulcerative Colitis –
– Conference call scheduled for 8 a.m. today
–
Seres Therapeutics, Inc., (NASDAQ:MCRB) today announced positive
topline results from a SER-287 Phase 1b placebo-controlled
induction study in 58 patients with mild-to-moderate Ulcerative
Colitis (UC), who were failing current therapies. Study data
demonstrate that SER-287, a microbiome therapy containing a
consortium of live bacterial spores, resulted in a benefit in
clinical remission rates, and also an improvement in mucosal
appearance by endoscopy. The SER-287 safety and tolerability
profile, a co-primary study endpoint, demonstrated no clinically
significant safety findings. Microbiome study results, a co-primary
endpoint, are expected in the coming months.
“We are extremely pleased with these SER-287 Phase 1b efficacy
and safety study results. The clinical data demonstrate the
potential for microbiome therapeutics to provide an effective and
safer alternative treatment modality for patients suffering from
Ulcerative Colitis,” said Roger J. Pomerantz, M.D., President,
Chief Executive Officer and Chairman of Seres. “Based on the
strength of these data, Seres intends to work expeditiously to
advance SER-287 into more advanced development studies. We plan to
further evaluate SER-287 in mild, moderate and severe forms of
Ulcerative Colitis, in maintenance after induction therapy, and we
also intend to assess development in Crohn’s disease, and pediatric
forms of inflammatory bowel disease. We expect to discuss these
data with the FDA as soon as possible, to determine the most
accelerated path to advance SER-287 development.”
“New treatment modalities are urgently needed that both address
the inadequate levels of remission with available Ulcerative
Colitis therapies, and have a favorable safety profile. The dose
dependent and highly positive clinical remission rates and
endoscopic scores from this study are very encouraging. SER-287 may
represent an important new treatment option for patients,” said
Stephen B. Hanauer, M.D., Professor of Medicine, Gastroenterology
and Hepatology, Feinberg School of Medicine at Northwestern
University, Chicago, Illinois.
Study Design
The SER-287 Phase 1b study, a randomized, double-blinded,
placebo-controlled, multiple-dose, induction study enrolled
patients with mild-to-moderate Ulcerative Colitis, with Mayo scores
of 4 to 10. The study enrolled 58 patients at 20 sites across the
United States. Twenty-four patients were classified as having mild
disease, and 33 patients had moderate disease. Study subjects
exhibited pre-study disease activity despite use of current
therapies in a majority of subjects, which included
5-amino-salacylic acid, low dose corticosteroids, or
immunomodulatory therapy.
Patients were randomly 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 vancomycin
pre-treatment, a weekly dosing arm, and a weekly dosing arm with
vancomycin pre-treatment. The co-primary study objectives were to
evaluate safety and tolerability, and the change in the microbiome
at up to 8 weeks after dosing. The secondary efficacy endpoints
included clinical remission rates, endoscopic improvement and
clinical response, assessed by a total modified Mayo score and
endoscopy, which, of importance utilized a central reader. The Mayo
score includes measures of stool frequency, rectal bleeding, the
physician’s global assessment, and an endoscopic evaluation.
Regulatory guidance from both the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA) for Ulcerative
Colitis, both issued in 2016, recommends the use of clinical
remission, including endoscopic improvement, as the primary
endpoint in all registrational studies.
Efficacy and Safety Results
Study efficacy related analysis is based on intent to treat
‘observed case’ data in 53 patients. Eight-week results demonstrate
that SER-287 administration resulted in a dose dependent
improvement of clinical remission rates and an improvement in
endoscopic scores. Data suggest that the most significant treatment
effect occurred in patients treated with the daily dose of SER-287.
Vancomycin addition to the regimen did not clearly alter efficacy
effects.
Summary of efficacy results:
Endpoint
Intent to Treat Population, Observed Case: Treatment
Group
Placebo / Placebo (N = 10)
(%)
Vancomycin / SER-287 Daily
(N = 15) (%)
Placebo / SER-287 Weekly
(N = 14) (%)
Vancomycin / SER-287 Weekly
(N = 14) (%)
Clinical Remission1 1/10 (10.0)4
6/15 (40.0) 2/14 (14.3) 3/14 (21.4)
Difference from placebo (SER-287 minus placebo)
30.0% 4.3% 11.4%
Endoscopic Improvement2 1/10
(10.0)
6/15 (40.0) 5/14 (35.7) 4/14
(28.6) Difference from placebo (SER-287 minus placebo)
30.0% 25.7% 18.6%
Clinical Response3 6/10
(60.0) 9/15 (60.0) 6/14 (42.9) 4/14 (28.6)
Difference from placebo (SER-287 minus placebo)
0.0%
-17.1%
-31.4% 1.
Clinical remission was defined as a total modified Mayo score of
less than or equal to 2, and an endoscopic sub-score of 0 or 1. 2.
Endoscopic improvement was defined as a decrease in endoscopic sub
score of greater than or equal to 1. Endoscopy measures were
analyzed by a Central Reader 3. Clinical response was defined as a
decrease of 3 or more points in total modified Mayo score from
baseline along with either a decrease of greater than or equal to 1
point in the rectal bleeding sub score, or an absolute rectal
bleeding sub score of 0 or 1. Clinical response did not require a
change in endoscopic score. 4. A patient in the placebo study arm
experienced a disease flare and was treated with corticosteroids
prior to the end of treatment endoscopy. Endoscopy showed
improvement and the patient was assessed as having achieved
clinical remission.
Diverse analyses of microbiome data of patients in this trial, a
co-primary endpoint, are expected to be completed in the coming
months. Three SER-287 drug product lots, based on human donor
material obtained from three separate individuals, were used in the
Phase 1b study. Microbiome analyses will also be conducted to
determine whether there are any recognizable differences in the
drivers of response across the drug product lots.
An evaluation of SER-287 safety and tolerability was a
co-primary study endpoint. The company believes the SER-287 safety
and tolerability profile was very favorable, and study results
demonstrated no imbalance in adverse events in SER-287 treated
patients, as compared to patients treated with placebo. There were
no drug related serious adverse events associated with SER-287.
The Company intends to present detailed study results at a
future medical/scientific meeting.
In addition to SER-287, Seres’ inflammatory bowel disease
microbiome pipeline includes SER-301, a therapeutic candidate
comprised of a consortium of rationally selected, fermented
bacterial species. The pending SER-287 microbiome data will be used
to inform the final composition of SER-301, as the Company plans a
SER-301 Investigational New Drug (IND) application.
Conference Call Information
Seres management will host a conference call today, October
2, 2017, at 8:00 a.m. ET. A webcast of the conference call, as
well as accompanying slides, may be accessed in the Investors &
Media section of Seres’ website at www.serestherapeutics.com.
To participate in the conference call, please dial (844) 277-9450
(domestic) or (336) 525-7139 (international) and provide conference
ID number 94507828.
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.
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.1
About Ulcerative Colitis
Ulcerative Colitis 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 Ulcerative Colitis 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. 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.
References
1.
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.
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 our plans to rapidly advance the development of SER-287,
the conduct and expected timing of microbiome study results related
to the SER-287 Phase 1b study, microbiome therapeutics’ ability to
provide an effective and safer alternative treatment for Ulcerative
Colitis, the evaluation and assessment of SER-287 in inflammatory
bowel disease, our discussions with the FDA related to SER-287,
SER-287 as an important new treatment option for patients, the
favorability of the safety and tolerability profile of SER-287, the
presentation of detailed study results for SER-287 at a
medical/scientific meeting, and plans for an IND application for
SER-301.
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; antikickback, 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
United States patent law; potential lawsuits for infringement of
third-party intellectual property; our patents being found invalid
or unenforceable; compliance with patent regulations; claims
challenging the inventorship or ownership of our patents and other
intellectual property; claims asserting that we or our employees
misappropriated a third-party’s intellectual property or otherwise
claiming ownership of what we regard as our intellectual property;
adequate protection of our trademarks; ability to attract and
retain key executives; managing our growth could result in
difficulties; risks associated with international operations;
potential system failures; the price of our common stock may
fluctuate substantially; our executive officers, directors, and
principal stockholders have the ability to control all matters
submitted to the stockholders; a significant portion of our total
outstanding shares are eligible to be sold into the market;
unfavorable or lacking analyst research or reports; 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 August 3, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171002005532/en/
IR or PR:Seres TherapeuticsCarlo Tanzi, Ph.D.,
617-203-3467Head of Investor Relations and Corporate
Communicationsctanzi@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Seres Therapeutics (NASDAQ:MCRB)
Historical Stock Chart
From Sep 2023 to Sep 2024