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Seres - Model SER-109 C. Difficile - First-In-Class Investigational Microbiome Therapeutic
SER-109 is a first-in-class investigational microbiome therapeutic administered orally following antibiotics to reduce recurrence of C. difficile infection (CDI) in patients with recurrent CDI.
SER-109 is comprised of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. The FDA has granted SER-109 Breakthrough Therapy Designation and Orphan Drug Designation. In a Phase 3 clinical trial, SER-109 achieved high rates of sustained clinical responses with a favorable safety profile comparable to placebo in patients with recurrent CDI. Data suggests enriching for Firmicutes spores achieves high efficacy, while mitigating risk of transmitting infectious agents beyond donor screening alone. For information on the prior clinical studies of SER-109, see here. Seres has completed enrollment in the SERES-013 ECOSPOR IV open-label study for SER-109. The open-label study is expected to expand the SER-109 safety database to support a Biologics License Application (BLA) with the US FDA. For more information about the open-label study of SER-109 see here.
SER-109 is a multifunctional consortium of commensal bacteria based on human clinical insights. It is designed to modulate the following microbiome functions:
C. difficile has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC) in 2019. It is the leading cause of hospital-acquired infection in the United States and is responsible for the deaths of more than 20,000 Americans each year.
There are few options for the treatment of recurrent CDI; vancomycin pulse taper regimens are recommended by guidelines but have modest efficacy because they do not address the disrupted microbiome (McDonald, 2018).
SER-109 engraftment is associated with compositional and functional changes in the microbiome that are critical to a sustained clinical response.
Status of clinical programSeres has completed enrollment of a Phase 3 ECOSPOR study assessing the safety and efficacy of SER-109 for the treatment of recurrent C. difficile. Patients may still enroll in an open-label study.