Seres Completes Rolling BLA Submission To FDA For SER-109 For Prevention Of RCDI

(RTTNews) - Microbiome therapeutics company Seres Therapeutics (MCRB) announced that it has completed the rolling submission process for its Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for SER-109 for the prevention of recurrent C. difficile infection (rCDI).

SER-109 is an entirely new treatment modality that shows promise to improve the current standard of care for rCDI.

Lisa von Moltke, MD, Chief Medical Officer at Seres, said, "Completing this BLA submission marks a key milestone for Seres and, more importantly, a potential turning point for the treatment of nearly 170,000 cases of recurrent C. difficile infection each year in the United States alone."

SER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA. If granted, Seres anticipates the potential approval and launch of SER-109 in the first half of 2023, with SER-109 potentially becoming the first ever FDA-approved oral microbiome therapeutic.