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Seres Therapeutics Announces Publication of Positive SER-109 Phase 1b/2 Study Results in The Journal of Infectious Diseases

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced that positive results from the Phase 1b/2 study of SER-109 in recurrent Clostridium difficile infection (CDI) were published today in The Journal of Infectious Diseases.

“These results demonstrate the potential of SER-109 to effectively treat recurrent CDI. With current treatment approaches having significant limitations, SER-109 has the potential to fundamentally change the management of this urgent health issue.”

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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. Stuart H. Cohen, MD, Chief, Division of Infectious Diseases, University of California, Davis. “These results demonstrate the potential of SER-109 to effectively treat recurrent CDI. With current treatment approaches having significant limitations, SER-109 has the potential to fundamentally change the management of this urgent health issue.”

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 Roger Pomerantz, MD, President, Chief Executive Officer and Chairman of Seres. “We are now building on these important results by advancing our ongoing SER-109 Phase 2 study in recurrent CDI and by developing SER-262, a synthetically derived product candidate, for patients with primary CDI. The microbiome represents a critically important new modality to address CDI and multiple other clinical indications, and we are proud to be leading the way. Our goal is for all patients with CDI, whether primary or recurrent, to be treated with a Seres microbiome drug to stop recurrence in this expanding epidemic in the United States and around the world.”

Study Details

The Phase 1b/2 open-label, single arm, descending-dose study enrolled 30 patients with recurrent CDI at four leading medical centers in the United States: Massachusetts General Hospital in Boston, Mass.; Mayo Clinic in Rochester, Minn.; Miriam Hospital in Providence, R.I., and Emory University Hospital in Atlanta, Ga. All enrolled patients received standard-of-care antibiotic treatment, followed by oral administration of SER-109.

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...


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