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FDA designates microbiome-based therapy as breakthrough for recurrent C. difficile
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Seres Therapeutics today announced its lead product candidate, SER-109, for prevention of recurrent Clostridium difficile infection has received breakthrough therapy designation by the FDA, according to a press release.
“Recurrent CDI is a life-threatening condition affecting between 85,000 and 110,000 people each year in the United States,” Roger Pomerantz, MD, chairman, president and CEO of Seres, said in the release. “We are encouraged by the FDA’s grant of breakthrough therapy designation for SER-109 and the potential for an expedited review by the FDA of our lead product candidate.”
SER-109 (firmacute eubacterial spores, purified suspension, encapsulated) is the lead Seres Ecobiotic microbiome therapeutic currently under investigation for treating recurrent C. difficile infection, the release said. A phase 2 randomized, placebo-controlled trial is currently enrolling, and aims to determine efficacy and safety of single-dose orally administered SER-109 after standard of care antibiotics, with a primary outcome measure of absence of C. difficile infection through 8 weeks compared with placebo. According to the release, the trial will involve 35 U.S. centers, and estimated completion will be the middle of 2016.
Disclosures: Pomerantz is an employee of Seres Therapeutics.