CAMBRIDGE, MA, USA I May 2, 2016 I Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics platform company, announced today that the target enrollment of 87 patients has been achieved for its ongoing SER-109 Phase 2 clinical study. SER-109 is an oral, potential first-in-field microbiome therapeutic that has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA), and is being investigated for use in preventing recurrent Clostridium difficile infection (CDI).
“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 Roger Pomerantz, M.D., Chairman, President, and CEO of Seres. “C. difficile infection is an extremely serious condition responsible for approximately 29,000 deaths each year in the United States alone. We are moving with urgency to develop SER-109 as quickly and safely as possible. We expect initial results of the Phase 2 study in the middle of this year, and we plan to initiate a Phase 3 study later in 2016.”
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 Journal of Infectious Disease.1
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 Seres Therapeutics
Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI) and is currently being evaluated in a Phase 2 study in recurring CDI. The FDA has granted SER-109 Orphan Drug, as well as Breakthrough Therapy, designations. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.
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 Centers for Disease Control. CDI is a rapidly growing problem associated with antibiotic use. It is a leading cause of hospital acquired infection in the U.S. and is responsible for the death of approximately 29,000 Americans each year. The incidence of first occurrence is between approximately 640,000 and 820,000 patients per year in the U.S., and approximately 85,000 to 110,000 CDI patients in the U.S. have more than one recurrence each year.
Reference
1. Khanna S. et al., A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent Clostridium difficile infection, Journal of Infectious Disease, 2016.
SOURCE: Seres Therapeutics
