Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study for the Prevention of Recurrent Clostridium difficile Infection
Phase 2 data expected in mid-2016
New SER-109 Expanded Access Program initiated at Phase 2 clinical sites
“We are pleased to reach this important milestone in our ongoing
development of SER-109, which has the potential to be the first therapy
for C. difficile infection to treat the underlying cause of this
disease, and the first microbiome drug for a human disease. This is the
first placebo controlled trial for patients with multiply-recurrent
CDI,” said
The SER-109 Phase 2 study (ClinicalTrials.gov identifier: NCT02437487)
is a multicenter, randomized, placebo-controlled study being conducted
at approximately 40 centers across the U.S. The current study builds on
a completed, successful Phase 1b/2 trial, which demonstrated that 87
percent of patients (26 of 30) met the predefined endpoint of preventing
recurrent CDI within eight weeks following administration of SER-109. In
that study 97 percent of patients (29 of 30) achieved a clinical cure
during the eight-week period after SER-109 dosing, as defined by the
absence of CDI requiring antibiotic treatment. Results from the Phase
1b/2 have been published in
The Company has initiated a SER-109 Expanded Access Program at selected sites participating in the ongoing Phase 2 study. The Expanded Access Program will enable eligible patients with multiply-recurrent CDI to have continued access to SER-109. Furthermore, maintaining Phase 2 study sites open ahead of the anticipated start of the Phase 3 study expected to support and augment Phase 3 study execution and enrollment.
About
About Clostridium difficile infection
Clostridium
difficile infection (CDI) is one of the top three most urgent
antibiotic-resistant bacterial threats in the U.S., according to the
Reference
1. Khanna S. et al., A novel microbiome therapeutic increases gut
microbial diversity and prevents recurrent Clostridium 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 timing of results from the Phase 2 clinical trial of SER-109, plans to initiate a SER-109 Phase 3 study later this year, the value for the Phase 3 study of the Expanded Access Program and the potential of SER-109 to be the first therapy for Clostridium difficile infection to treat the underlying cause of the disease.
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: 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 our ability to commercialize our product candidates
and affect our ability to generate revenue; our reliance on our
collaboration with Nestlé to develop and commercialize our CDI and IBD
product candidates; 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; protection of our proprietary technology; protection
of the confidentiality of our trade secrets; changes in
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Source:
IR and PR Contact:
Seres
Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor
Relations and Corporate Communications
ctanzi@serestherapeutics.com