Conference report: Positive data from phase 3 ECOSPOR III study evaluating SER-109 in recurrent C.difficule infection (rCDI)
Exploratory analysis found SER-109, an investigational oral microbiome consisting of a consortium of highly purified Firmicutes spores, reduced the risk of rCDI vs placebo in patients with risk factors for recurrence, including those taking acid suppressants (40.7% of patients).
Source:
Biospace Inc.
SPS commentary:
Previously reported data demonstrated that the study achieved its primary endpoint where SER-109 was superior to placebo in reducing CDI recurrence at eight weeks (27% absolute reduction). The company expects both the completed Phase 3 study results and the pending open-label study database to enable a Biologics License Application filing with FDA in mid-2022 .