EnteroBiotix secures key additional MHRA license and announces regulatory milestones

EnteroBiotix, a leading clinical stage microbiome therapeutics company headquartered in Aberdeen, Scotland, today announced that it has secured a Manufacturer's Authorisation for Investigational Medicinal Products MIA (IMP) license from the Medicines and Healthcare Products Regulatory Agency (MHRA). The Manufacturers Authorisation for IMPs is an EU requirement for the production of material for patient use in clinical trials. The license enables EnteroBiotix to manufacture intestinal microbiome-derived medicinal products for use in EnteroBiotix-sponsored and investigator-led clinical trials. On the back of this success, the company plans to announce its clinical trial pipeline and distribute products to trial participants towards the end of this year.

In August 2018, EnteroBiotix announced that the company had been awarded a manufacturer's specials license from the MHRA. Since then, EnteroBiotix has distributed products to hospitals in the UK and the EU on a named patient basis. The announcement of this additional IMP license, which follows a substantial seed-extension investment announced in May, will catalyse the launch of a number of pioneering clinical trials later this year.

EnteroBiotix is also announcing that it has made significant progress with regulatory authorities and its product development pipeline. Last month, Dr James McIlroy MBChB, Founder and President of EnteroBiotix, delivered a presentation and led discussions on behalf of the company at an Innovation Task Force meeting held at the European Medicines Agency (EMA) in Amsterdam. Dr McIlroy was supported by Nicolas Robinson CSci, Director of Production at EnteroBiotix, Professor Dilip Nathwani OBE, Clinical Advisor to EnteroBiotix, and a team of regulatory specialists. The ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the EMA and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.

In parallel with these developments, the company is also announcing that, EnteroBiotix, Caelus Health, Ferring Pharmaceuticals, and MaaT Pharma, in coordination with the Pharmabiotic Research Institute (PRI), have established a joint collaboration focused on creating a proposal with recommendations for a common European regulatory framework for human intestinal microbiome ecosystem-based therapeutics. Through this new collaboration, IMM-ETG hopes to gain valuable insight and feedback from the competent authorities with the aim of establishing a harmonised regulatory landscape for related products across the European Union.

Dr James McIlroy MBChB, Founder and President of EnteroBiotix, said: "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. 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."

About EnteroBiotix

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.