Seres Therapeutics Announces FDA Orphan Drug Designation for SER-287 in Treatment of Pediatric Ulcerative Colitis
December 04 2017 - 7:00AM
Business Wire
Seres Therapeutics, Inc., (NASDAQ:MCRB) today
announced that the U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation to microbiome therapeutic candidate
SER-287 for the treatment of Ulcerative Colitis (UC) in pediatric
patients.
Orphan Drug Designation provides incentives designed to advance
drug development for rare diseases or conditions that affect fewer
than 200,000 people in the United States. The FDA’s
designation of SER-287 follows a review of data which established a
medically plausible basis for the use of SER-287 – specifically,
the Phase 1b clinical data that highlights the potential of SER-287
as a novel treatment modality for patients suffering from UC.
Seres successfully completed a placebo-controlled Phase 1b study
of SER-287 in patients with mild-to-moderate UC who were failing
current therapies. SER-287 administration resulted in a
dose-dependent improvement of both clinical remission rates and
endoscopic scores, and demonstrated a very favorable safety
profile. The Phase 1b results demonstrate the potential for SER-287
to provide an effective and safer alternative treatment modality
for patients suffering from UC. SER-287 Phase 1b microbiome data
are expected in early 2018.
“We are pleased to receive FDA Orphan Drug Designation for
SER-287 and we look forward to advancing the program into further
development for Ulcerative Colitis. Based on the highly encouraging
Phase 1b clinical results and favorable safety profile, we intend
to evaluate SER-287 in a pediatric UC population as part of our
overall development plan. Safety is of particular importance to the
pediatric population, and given the positive safety profile
observed in our clinical trial to date, we believe our microbiome
approach may be well suited to address this group,” said Roger J.
Pomerantz, M.D., President, CEO and Chairman of Seres.
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 thereby 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 J.M. 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 the timing of microbiome data, the potential for SER-287
to treat UC patients, including pediatric UC patients, the timing
of 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 lesd 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171204005243/en/
IR or PR:Seres TherapeuticsCarlo Tanzi, Ph.D.,
617-203-3467Head of Investor Relations and Corporate
Communicationsctanzi@serestherapeutics.com
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