Seres Therapeutics Receives FDA Breakthrough Therapy Designation

Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, today announced that SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), its lead product candidate under investigation for the prevention of recurrent Clostridium difficile infection (CDI) in adults, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA). Breakthrough therapy designation is intended to expedite the development and review of therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. This designation allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review (if supported by clinical data at the time of submission).