Seres Therapeutics to Initiate New SER-109 Clinical Study
– Positive SER-109 Type B FDA meeting –
– Seres and
– New trial may qualify as a Pivotal Study with achievement of a
persuasive clinical effect and addressing
– Conference call at
Seres plans to initiate a new SER-109 clinical study in approximately
320 patients with multiply recurrent C. difficile infection.
Study participants will be randomized 1:1 between SER-109 and placebo.
To ensure accurate measurement of C. difficile infection,
diagnosis of recurrent C. difficile infection for both
study entry and for endpoint analysis will be confirmed by C.
difficile cytotoxin assay. Patients in the SER-109 arm will receive
a total SER-109 dose, administered over three days, approximately
10-fold higher than the dose used in the prior ECOSPOR study. ECOSPOR
III will evaluate patients for 24 weeks and the primary endpoint will
compare the C. difficile recurrence rate in subjects who receive
SER-109 verses placebo at up to eight weeks after dosing. The
“We are pleased to have received highly constructive guidance from the
Conference Call Information
Seres’ management will host a conference call today,
About SER-109
SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state.
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 SER-109 development plans, the timing, design, and results of the ECOSPOR III study , the potential for ECOSPOR III to provide different results than the previous ECOSPOR study, the impact analysis of prior clinical studies may have on clinical outcomes, the potential for ECOSPOR III to qualify as a Pivotal Study, dysbiosis as an underlying cause of C. difficile and other diseases.
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; anti-kickback, 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170316005279/en/
Source:
Seres Therapeutics, Inc.
Carlo Tanzi, Ph.D., 617-203-3467
Head
of Investor Relations and Corporate Communications
Ctanzi@serestherapeutics.com