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
The FDA previously issued a safety alert on
Seres’ 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.
Seres 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 intervention to increase quality assurance and minimize the risk to patients.
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 statements relating to FDA approval of Seres’ therapeutic candidates. Any forward-looking statements represent management’s opinions as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our unproven approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; that we have no experience manufacturing products at commercial scale; our products may become subject to unfavorable pricing restrictions; we may face product liability lawsuits; we may face competition from biosimilars; our ability to protect our trade secrets and know-how; potential changes in