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87 percent of patients with recurrent C. difficile infection met primary endpoint; 97 percent achieved clinical cure
The study evaluated the efficacy and safety of SER-109 for recurrent CDI, and measured corresponding alterations in the gut microbiota. Results 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. Most importantly, 97 percent of patients (29 of 30) achieved clinical cure during the eight-week period after SER-109 dosing, as defined by the absence of CDI requiring antibiotic treatment. By contrast, the expected cure rates in people treated with the standard of care, i.e. antibiotics, for recurrent CDI range from 23-31 percent, according to a recent well-controlled study.1
“The impressive level of efficacy observed with SER-109 treatment is
striking when compared with the high rate of recurrence expected in this
population,” said Dr.
SER-109 induced clinical cures occurred in parallel with a rapid and sustained remodeling of the gut microbiome, supporting the treatment premise, i.e. mechanism of action, that addressing the underlying dysbiosis (unhealthy microbiome) that gives rise to CDI will produce a profound clinical benefit.
“This study showed that we can address the root cause of C. difficile
infection by inducing a healthy and diverse microbiome,” said
The Phase 1b/2 open-label, single arm, descending-dose study enrolled 30
patients with recurrent CDI at four leading medical centers in
Of the 30 study patients, 26 (87%) achieved the primary endpoint of absence of diarrhea with a positive C. difficile test up to eight weeks following dosing. Three of the four patients who did not meet the primary endpoint were determined by their primary investigator to be recovering from CDI, and all symptoms resolved without further therapeutic intervention or antibiotics. In total, 29 of 30 patients (97%) achieved full clinical cure of recurrent CDI following SER-109 administration.
SER-109 was well tolerated in the study, with the most common adverse events being mild to moderate gastrointestinal symptoms. No drug related serious adverse events were observed.
In a corresponding finding, microbial diversity increased significantly at eight weeks, driven by engraftment of SER-109 related microbiota, as well as the augmentation of key bacterial species following administration. The reduction or elimination of pathobionts, species that colonize the gut and can cause infection in susceptible individuals, was observed in a majority of patients. These changes were detected as early as day four and were durable through 24 weeks of observation, with subjects’ microbiomes returning to a state reflective of healthy individuals.
SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to a healthier state.
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
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 potential of SER-109 to treat CDI and fundamentally change the management of CDI, and dysbiosis of the microbiome as an underlying cause of CDI.
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;
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor Relations and Corporate Communications
Ten Bridge Communications, Inc.
Dan Quinn, 781-475-7974