Seres Therapeutics Announces FDA Orphan Drug Designation For SER-109

(RTTNews) - Seres Therapeutics Inc. (MCRB), a microbiome therapeutics platform company, announced that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to SER-109, an oral therapeutic currently in a Phase 2 clinical trial for the prevention of recurrent Clostridium difficile infection or CDI in adults.

SER-109 is being investigated as a new therapeutic modality to treat recurrent CDI by correcting a dysbiosis of the human microbiome, which is an underlying cause of the condition.

Results from a Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients achieved efficacy endpoint per protocol, and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.

Seres is currently conducting a multicenter, randomized, placebo-controlled Phase 2 clinical study to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The primary outcome measure is the absence of CDI through eight weeks following administration of SER-109 compared to placebo. It expects the results from this study to be available in the middle of 2016.

In addition to Orphan Designation, in June 2015, SER-109 was granted Breakthrough Therapy Designation by the FDA, which is intended to expedite the development and review of therapeutics for serious conditions that may demonstrate a substantial improvement over existing therapies, based on preliminary clinical evidence.