EnteroBiotix secures MHRA licence for clinical trial manufacturing

The Scottish microbiome specialists is also working on creating a common European regulatory framework for microbiome ecosystem-based therapeutics

Dr James Mcllroy, Founder and President of EnteroBiotix

EnteroBiotix has secured a Manufacturer’s Authorisation for Investigational Medicinal Products MIA (IMP) license. The IMP lisence is an EU requirement of the MHRA for the production of material for patient use in clinical trials.

The license enables the Scotland-based microbiome specialists 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. Showing the company's interest and expertise in the field.

In parallel with this development, the company is also announcing a joint collaboration of EnteroBiotix, Caelus Health, Ferring Pharmaceuticals, and MaaT Pharma, in coordination with the Pharmabiotic Research Institute (PRI).

The collaboration will be focused on creating a proposal with recommendations for a common European regulatory framework for human intestinal microbiome ecosystem-based therapeutics.

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,” he added.