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news.Seres Therapeutics has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its lead product candidate SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), being evaluated to prevent recurrent Clostridium difficile infection (CDI) in adults.
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Currently, the company is carrying out a multicenter, randomized, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SER-109 in prevention of recurrent CDI.
The trial’s primary outcome measure is the absence of CDI through eight weeks, following administration of SER-109 compared to placebo.
Seres chairman, president and CEO Roger Pomerantz said: "Recurrent CDI is a life-threatening condition affecting between 85,000 and 110,000 people each year in the US.
"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."
The company said that they are actively enrolling patients in the trial, which is expected to be conducted at about 35 centers across the US.
During the trial, SER-109 will be administered orally as a single dose, following administration of the standard of care antibiotics for CDI, a rapidly growing problem associated with antibiotic use.
SER-109 was developed using the company’s Microbiome Therapeutics platform that provides insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health.
Image: Seres is currently conducting a Phase II trial to evaluate the efficacy and safety of SER-109 in prevention of recurrent CDI. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.