Seres Therapeutics Inc (NASDAQ:MCRB) has announced the publication of data from Phase 3 ECOSPOR III study SER-109 for recurrent C. difficile infection (rCDI).
- The New England Journal of Medicine (NEJM) publication highlights that SER-109 was superior to placebo in reducing CDI recurrence, with 88% of SER-109 patients achieving a sustained clinical response compared to 60% on placebo.
- SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which generally live in a healthy microbiome.
- Related: Nestlé Bets $525M On Seres Therapeutics Microbiome Drug For Infectious Diseases.
- SER-109 was also well-tolerated, with a side effect profile comparable to placebo and no serious drug-related adverse events observed.
- Seres expects to finalize a marketing application submission for SER-109 with the FDA in mid-2022.
- In November, Seres recruited Bacthera to manufacture SER-109.
- Bacthera will establish a new Microbiome Center of Excellence dedicated to live biotherapeutic product (LBP) manufacturing at Lonza's site in Visp, Switzerland.
- The 12,000 m2 Microbiome Center of Excellence will have three manufacturing floors, including capacity for commercial production. One of the three manufacturing floors will be dedicated to the manufacturing of SER-109.
- Price Action: MCRB shares closed 4.36% higher at $7.90 during after-hours trading on Wednesday.
