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Seres Therapeutics Issues Statement Regarding U.S. Food and Drug Administration’s March 12, 2020 Safety Alert Related to Use of Fecal Microbiota Transplantation
FDA alert is related to unapproved fecal microbiota transplantation (FMT) and does not impact Seres’ investigational microbiome therapeutic candidates
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\nFDA alert is related to unapproved fecal microbiota transplantation (FMT) and does not impact Seres’ investigational microbiome therapeutic candidates\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB) today provided a statement on a safety alert from the U.S. Food and Drug Administration (FDA) regarding bloodstream infections with multi-drug resistant organisms (MDROs) transmitted through fecal microbiota transplantation (FMT). On March 12, 2020, the FDA stated that it became aware of six infections caused by enteropathogenic Escherichia coli (EPEC) and Shiga toxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT. The FDA suspects that these infections were due to transmission of pathogenic organisms from FMT product supplied by a stool bank company based in the United States. Four of the six patients who received the contaminated FMT required hospitalization. An additional two patients who received FMT from the STEC-positive donor died.\n\n\nThe FDA previously issued a safety alert on June 13, 2019, stating that two immunocompromised adults who received FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing E. coli, and that one individual died.\n\n\nSeres’ therapeutic candidates, including its SER-109 product candidate currently under investigation in a Phase 3 study for recurrent C. difficile infection, are comprised of highly purified consortia of spore-based commensal bacteria. SER-109 is manufactured under Good Manufacturing Practices (GMP) conditions and is quality-controlled using stringent standards to ensure product quality and consistency. In addition to conducting rigorous donor screening, Seres utilizes a unique manufacturing process that has been demonstrated to inactivate numerous potential pathogens, including species of vegetative bacteria such as Escherichia coli and viruses. The Company’s manufacturing process effectively inactivates emerging potential pathogens where diagnostic assays may not yet be available, such as SARS-CoV-2, the virus linked to COVID-19.\n\n\nSeres believes that donor and product screening are necessary but insufficient to minimize infection risk for donor-derived microbiome and FMT products. Seres’ additional step of inactivation of potential pathogens represents a critical i...