EXHIBIT 99.2
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Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECOSPOR IV Open-Label Study in Recurrent C. Difficile Infection
– ECOSPOR IV study shows favorable safety profile through 24-week follow-up, consistent with the safety profile observed in ECOSPOR III study
– 91.3% sustained clinical response achieved at eight weeks in overall population with consistent results in key subpopulations including first recurrence –
– Rolling Biologics License Application (BLA) submission initiated and on track for mid-2022 completion –
– Conference call at 8:30 a.m. ET today –
CAMBRIDGE, Mass., June 7, 2022 — Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced confirmatory results from ECOSPOR IV, an open-label study for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI). The overall safety profile observed in ECOSPOR IV through 24 weeks indicated that SER-109 was well tolerated, consistent with the safety profile observed in the prior placebo-controlled ECOSPOR III study. The ECOSPOR III and ECOSPOR IV studies together 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, consistent with the 88% rate observed in the ECOSPOR III study. Subjects with a first recurrence of CDI (29% of subjects in the ECOSPOR IV study) had a CDI recurrence rate of 6.5%, and subjects with ≥ two prior CDI episodes (ECOSPOR III inclusion criteria) had a CDI recurrence rate of 9.7% at eight weeks. At 24 weeks, 13.7% of all subjects treated with SER-109 had a recurrence of CDI. The data from this study help complete the U.S. Food and Drug Administration’s (FDA’s) predefined safety database requirements for SER-109.
“The ECOSPOR IV data confirm the well-tolerated safety profile and substantial clinical benefit observed in the prior ECOSPOR III study,” said Eric Shaff, President and Chief Executive Officer at Seres. “These results, along with the start of the rolling BLA submission, significantly advance our ability to deliver what may be the first FDA-approved microbiome therapeutic. We believe that SER-109 has the potential to fundamentally transform the management of rCDI across all 170,000 annual cases in the U.S. and are working closely with Aimmune Therapeutics, a Nestlé Health Science Company, to bring this therapeutic candidate to patients as quickly as possible.”
In addition to data from the SER-109 ECOSPOR III study (NCT03183128), the ECOSPOR IV data will be included as part of the rolling submission of the BLA to the FDA. While the ECOSPOR III data alone will serve as the basis for efficacy in Seres’ BLA submission, the FDA requested safety data from at least 300 subjects treated with SER-109 at the commercial dose as the basis