Seres Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SER-109

Industry News

Seres Therapeutics, a Cambridge, MA based biotechnology company has received Breakthrough Therapy Designation status for its lead product candidate, SER-109 from the U.S. FDA for the prevention of recurrent Clostridium difficile infection (CDI) in adults.  CDI is one type of healthcare-associated infections caused by the germ C. difficile and recurrent CDI is a life-threatening condition.  Patients who take antibiotics and are hospitalized are at high risk for this infection.  SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated) is the lead Ecobiotic microbiome product developed by the company’s technology platform and is a combination of a small number of selected discrete organisms that work by catalyzing a shift from a disease state to one of health.  Currently, Seres is conducting a Phase II clinical study to assess the efficacy and safety of SER-109 in prevention of recurrent CDI.


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