Massachusetts-based Seres Therapeutics, Inc. announced Tuesday that its Phase III Ecospor IV study exhibited a strong safety profile in addition to statistically significant positive results. The study utilizes an open-label design to determine the potential of SER-109, a potentially first-in-class microbiome therapeutic to treat recurrent C. difficile infection (rCDI).

The study is placebo-controlled, double-blinded, and randomized. The primary outcome measurement focuses on the participants’ infection recurrence after treatment for eight weeks. Infection is confirmed using a toxin assay. Secondary outcome measures examine recurrence rates at the 4, 12 and 24-month marks within each treatment group. Additional measurements look at the time to infection recurrence and sufficiency of the treatment.

SER-109 is an orally delivered therapeutic that produces purified firmicutes to the patient’s microbiome to prevent C. difficile colonies from forming. Firmicutes are a classification of bacteria that are critical to gut health, which in turn, plays a significant role in overall metabolic function. The candidate’s unique mechanism influenced the U.S. Food and Drug Administration’s (FDA) decision to grant Breakthrough Therapy and Orphan Drug designations for SER-109 when indicated to treat rCDI.

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