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Seres Health Completes Enrollment in a Clinical Study for SER-109 in Recurrent Clostridium difficile Infection and Announces Positive Preliminary Data
Date:7/16/2014

CAMBRIDGE, Mass., July 16, 2014 /PRNewswire/ -- Seres Health, a clinical-stage therapeutics company developing novel treatments for diseases related to the human microbiome, today announced that it has completed enrollment for its single-arm, open-label clinical trial of SER-109, its first-in-field, oral microbiome therapeutic designed for the treatment of recurrent Clostridium difficile Infection (CDI). CDI results from the prior use of antibiotics, which break down the protective function of a healthy microbiome. SER-109 is rationally designed to restore the microbiome of CDI patients to a state of health and thereby prevent recurrences. Preliminary data from the trial demonstrates the prevention of CDI recurrence in 29 of the 30 patients enrolled.

In Seres' trial, 30 patients with recurrent C. difficile, defined as two recurrences or more, were treated in two dose cohorts. Each patient stopped taking antibiotics and was orally administered SER-109 one day later. The primary efficacy endpoint of the study was the absence of recurrent CDI over an 8-week period and safety was assessed by regular phone contact and in-person physical exams.  All 15 patients in the first cohort reached the week 8 endpoint without requiring antibiotics and were CDI-free. In the second, lower dose cohort, which is in progress, 14 of the 15 patients enrolled have been successfully treated and are presently CDI free, 11 of whom have achieved the primary 8-week efficacy endpoint thus far. Genomic analysis of each patient's gastrointestinal microbiome, evaluated to date, demonstrates that SER-109 repairs dysbiosis caused by antibiotic treatment. These preliminary results suggest that SER-109 may have unprecedented efficacy for a drug combating recurrent CDI and has an excellent safety profile. Given these positive initial results, a late-stage trial is expected to start by the end of 2014. Seres will also be applying for Breakthroug
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