Seres Therapeutics Touts New Safety Data, Plans First FDA Approval For Microbiome Drug

• Seres Therapeutics Inc (NASDAQ:MCRB) announced confirmatory results from ECOSPOR IV, an open-label study for SER-109 to prevent recurrent C. difficile infection (rCDI). 
• The overall safety profile observed in ECOSPOR IV through 24 weeks indicated that SER-109 was well tolerated.
• The ECOSPOR III and ECOSPOR IV studies conclude the SER-109 Phase 3 development program.
• In ECOSPOR IV, subjects treated with SER-109 had a recurrence rate of 8.7% at eight weeks, which indicates a 91.3% sustained clinical response. 
• Also Read: Seres Therapeutics Ditches Its SER-301 Phase 1b Second Study In Ulcerative Colitis.
• At 24 weeks, 13.7% of all subjects treated with SER-109 had CDI recurrence.
• The company noted that less than 9% of treated patients experienced recurrence within eight weeks of treatment.
• Seres has initiated the rolling submission of the SER-109 BLA and anticipates completing the BLA submission by mid-2022. It anticipates a potential launch of SER-109 in 1H of 2023.
• Price Action: MCRB shares are up 11.6% at $3.61 during the market session on the last check Tuesday.