EnteroBiotix is aware of a safety alert issued by the FDA on 13/06/2019 regarding two patients who acquired Extended Spectrum Beta-Lactamase (ESBL)-producing Escherichia coli infections after receiving faecal microbiota transplantation (FMT). In the alert, the FDA state that the faecal microbiota transferred into the patients was derived from a donor that carried the ESBL producing organisms. Sadly, one of these patients was reported to have died as a result of the infection.
In response to this alert, we have reviewed our procedures and current practice against the recommendations made by the FDA and are of the view that the risk of a multi-drug resistant organism (MDRO) being present in any of EnteroBiotix’s products is very low.
The Company’s pathogen screening protocols are already compliant with the recommendations outlined in European and BSG/HIS consensus guidance and in light of this, the Company screens for Extended-spectrum beta-lactamase (ESBL) producing bacteria (including ESBL E.coli) and other drug resistant organisms such as Vancomycin-resistant Enterococcus (VRE) and Carbapenem-resistant Enterobacteriaceae (CRE). All tests are carried out in UKAS accredited laboratories and any positive result would exclude a prospective donor from becoming an active donor and would prevent an ‘active donor’ from donating any further. In the case of an ‘active donor’, if confirmatory testing was to yield a positive result, then EnteroBiotix would reject and destroy any donated material held in stock from that particular donor.
In addition to robust laboratory screening, the Company also screens prospective donors with questions that specifically address risk factors for the acquisition of MDRO’s. Active donors are also screened for risk factors before each donation.
EnteroBiotix is of the view that this tragic event highlights the need for any manufacturer of medicinal products derived from donor material to operate and adhere to appropriate and robust Quality Management Systems. The Company is also of the view that when industrially produced, facilities that manufacture such products should be licensed by a competent authority. EnteroBiotix’s Quality Management System and manufacturing facilities have been inspected and are licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA). EnteroBiotix holds an MHRA ‘Specials’ license, and an MHRA MIA (IMP) license. The Company has also discussed its screening protocols and manufacturing strategy with the European Medicines Agency (EMA) at a meeting with the EMA Innovation Task Force. Finally, any manufacturer and provider of such products has a duty of care to ensure that patients are appropriately informed of the risks associated with receiving a product manufactured using donor material. The Company’s product and patient information leaflets are appropriate in that respect.
As a licensed provider of products that can be used in FMT, EnteroBiotix has forged hospital partnerships in Scotland, England, Wales, Northern Ireland and Ireland. Ongoing management of product safety and quality assurance remains a top priority for the Company as we continue to serve hospitals, clinicians, researchers and patients. Please do not hesitate to contact us if you have any questions or queries relating to product safety.
EnteroBiotix is harnessing the human microbiome to develop novel medicinal products that restore health and prevent disease. The company’s first focus is to unlock the full therapeutic potential intestinal microbiome transfer through two core product portfolios targeting gastrointestinal diseases and infections caused by bacteria such as C.difficile. EnteroBiotix has established deep operational experience and capabilities, including fully integrated ISO-accredited microbial collection and GMP-compliant clean room manufacturing facilities under a manufacturer’s specials license (License Number: MS 49464) and an MIA (IMP) license (License Number: MIA(IMP) 49464) from the Medicines and Healthcare Products Regulatory Agency (MHRA). Since its formation in March 2017, EnteroBiotix has raised over £2.5m in seed investment and has distributed its market entry, minimally manipulated medicinal products on a named patient basis around Europe. EnteroBiotix has offices in Aberdeen, Scotland, and Boston, USA.