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

  • Seres Therapeutics Inc 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.
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