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
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
“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
“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
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
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
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 |
Vancomycin / |
Placebo / SER-287 |
Vancomycin / |
|||||||
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
About Seres Therapeutics
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
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
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/
Source:
IR or PR:
Seres Therapeutics
Carlo Tanzi, Ph.D.,
617-203-3467
Head of Investor Relations and Corporate Communications
ctanzi@serestherapeutics.com