Seres Therapeutics Presents Late-Breaking Phase 3 Data on Investigational Microbiome Therapeutic SER-109 in Recurrent C. Difficile Infection at American College of Gastroenterology 2021 Annual Scientific Meeting
– Study shows that SER-109 reduced the risk of recurrent C. difficile infection in patients with risk factors for recurrence, including acid-reducing medications –
“Those living with gastrointestinal issues are faced with limited treatment options to help address some of the debilitating symptoms they face each day. While many turn to acid-reducing medicines, previous studies have shown that this can result in a higher risk of recurrent C. difficile infection,” said
The SER-109 ECOSPOR III Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported topline data demonstrated that the study achieved its primary endpoint where SER-109 was superior to placebo in reducing CDI recurrence at eight weeks reflecting a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. In
“As a clinician treating people living with recurrent C. difficile infection, I recognize the serious and often debilitating impact it has on their lives. I’m further encouraged by these new findings as they show that SER-109 has the potential to be broadly effective, including in patients known to be at higher risk of experiencing a recurrence of C. difficile infection,” said
Seres expects both the completed Phase 3 study results and the pending open-label study database to enable a Biologics License Application (BLA) filing in mid-2022.
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome. SER-109 is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes thereby reducing the risk of pathogen transmission beyond donor screening alone. The
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the potential approval of SER-109 and its status as a first-in-class therapeutic, the timing of a BLA filing, the ultimate safety profile of SER-109, the potential of microbiome therapeutics to treat and prevent disease, the timing and results of our clinical studies, the ultimate safety and efficacy data for our products, and other statements which are not historical fact.
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