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).

“Recurrent CDI is a life-threatening condition affecting between 85,000 and 110,000 people each year in the United States,” said Roger Pomerantz, M.D., Chairman, President and CEO of Seres. “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.”

For more details, go to: http://www.reuters.com/article/2015/06/12/ma-seres-therapeutics-idUSnBw125297a+100+BSW20150612