In a statement, the company confirmed it received a Manufacturer’s Authorisation for Investigational Medicinal Products MIA (IMP) license from the Medicines and Healthcare Products Regulatory Agency (MHRA).
The licence essentially permits EnteroBiotix to manufacture intestinal microbiome derived medicinal products for use in EnteroBiotix-sponsored and investigator-led clinical trials.
It also allows the team to conduct more extensive, detailed clinical trials with real possibilities of getting its medical products to market.
“This additional MHRA license demonstrates that our approach in developing and advancing novel intestinal microbiome derived medicinal products is robust and that our best-in-class infrastructure is capable of large-scale delivery of safe products,” said Dr James McIlroy, founder and president of EnteroBiotix.
“We look forward to continuing to work with our collaboration partners and the inspectorate as we move towards distributing the first batches of potentially life-saving clinical material to patients in the UK and the EU.”
C. difficile infections
EnteroBiotix currently have two products available to clinicians that look to address Clostridium difficile infections and potentially other diseases.
These are ‘FM250,’ a 250 millilitre (ml) suspension of faecal microbiota intended for lower GI delivery and ‘FM125,’ a 125ml suspension of faecal microbiota intended for upper GI delivery.
The firm’s ongoing work also looks into the use of FMT in antibiotic resistant bacteria and the use of data generated from treatments to explain how FMT works.
The hope is that knowledge gained can help isolate the active ingredients and develop them as next generation therapeutics.
Approval by the MHRA means the company can announce its clinical trial pipeline and distribute products to trial participants towards the end of this year.
The licence approval closely follows a similar agreement back in August 2018, where EnteroBiotix were awarded a manufacturer’s specials license from the MHRA.
The license permitted EnteroBiotix to distribute products to hospitals in the UK and the EU on a named patient basis.
Microbiome task group
The firm were also part of a collaboration of European microbiome firms pushing for pan-EU regulation for microbiome-based therapeutics in efforts to keep pace with advances in FMT.
The Intestinal Microbiome-based Medicines European Task Group (IMM-ETG) included Caelus Health, Ferring Pharmaceuticals and MaaT Pharma along with the Pharmabiotic Research Institute (PRI).
Action to agree laws governing microbiome-based therapeutics comes as the EU commission reiterated its position stating that when administered into a recipient with therapeutic intention, the "active components" of the faecal microbiota are not the human cells.
In light of this, faecal microbiota is not considered as falling within the scope of Directive 2004/23/EC on human tissues and cells legislation and may be considered as a medicinal product.
“The IMM-ETG proposes that products defined as intestinal microbiome whole ecosystem-derived are medicinal products,” they said.
“This is in so far as they are intended to ‘treat or prevent disease in human beings’ and are to be regulated according to Directive 2001/83/EC across all EU Member States
“This is as long as they are ‘intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.”