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 Breakthrough Drug Status from the FDA. Final complete data and details on the study will be presented at an international conference in the fall of this year.
"The positive results of this trial are very encouraging and support the advancement of SER-109 into late-stage clinical studies for treating recurrent C. difficile, which is currently a real and increasing clinical challenge," said Elizabeth Hohmann, MD, Associate Professor of Medicine, Massachusetts General Hospital, one of the study investigators. "Of particular importance to patients and physicians, the oral capsules are a simple, efficacious alternative to other more invasive procedures."
"There is a critical need to identify an effective, orally delivered community of microbes, as a true drug, to treat this debilitating infection," said Dr. Roger J. Pomerantz, President, CEO and Chairman of Seres Health. "The clinical profile of SER-109 demonstrates the power of Seres' Microbiome TherapeuticsTM discovery platform and gives us high expectations for the advancement of Ecobiotic® candidates in our pipeline for first-line CDI and other serious infections, as well as metabolic disorders and inflammatory conditions."
SER-109 is the lead Seres Health Ecobiotic® microbial therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI), an orphan indication. SER-109 was developed utilizing the Seres Health Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health. CDI is a rapidly growing problem associated with antibiotic use. Approximately 100,000 - 150,000 of CDI patients in the U.S. have more than one recurrence. Multiple recurrent CDI has recently been designated as an Orphan Drug Indication by the FDA.
About Seres Health
Seres Health is a clinical-stage therapeutics company focused on discovering and developing Ecobiotic® therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs™, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. Seres recently announced a research agreement with Mayo Clinic and has received over $20 million in funding to date. For more information, please visit www.sereshealth.com.
For Seres Health: Emily Rossi
SOURCE Seres Health