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FDA grants orphan drug designation to SER-109 for preventing recurrent C. difficile infection

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The FDA has granted orphan drug designation to SER-109, an oral therapeutic in development for the prevention of recurrent Clostridium difficile infection in adult patients, the manufacturer announced.

According to a press release, a single dose of four SER-109 (Seres Therapeutics) capsules “reintroduces an ecology of purified bacterial spores which restore the microbiome to a healthy state” from a dysbiotic state, which may be induced or prolonged by antibiotics, which are currently the only FDA-approved treatment option for recurrent C. difficile infection.

“Receiving orphan drug designation from the FDA for SER-109 is another step on our path to bringing this important new medicine to patients in dire need of an effective, durable treatment. Moreover, it signifies a landmark event, as it marks the first microbiome drug to achieve this regulatory milestone, and is also rarely given for infectious disease indications,” Roger Pomerantz, MD, chairman, president and CEO of Seres, said in a press release. “SER-109 is intended to reintroduce essential bacteria that restore the body’s natural resistance to [C. difficile infection] by re-establishing the ecology of the colonic microbiome. Because we’re focused on treating the underlying cause of the disease, we believe we have the potential to break the cycle of recurrent [C. difficile infection] and have a significant impact for patients. We’re extremely pleased that we continue to make both clinical and regulatory progress, well positioning us to advance this radically new approach to address such a difficult and devastating infectious disease.”

SER-109 is currently being tested a multicenter, randomized, placebo-controlled phase 2 clinical trial for the prevention of recurrent C. difficile infection in adults, the results of which are expected in mid-2016, according to the release. In a previous phase 1b/2 study, 87% of patients with recurrent C. difficile infection achieved the per protocol efficacy endpoint and 97% achieved a clinical cure.

SER-109 was previously granted breakthrough therapy designation by the FDA in June 2015.

Disclosure: Pomerantz reports being employed by Seres Therapeutics.