EnteroBiotix secures key additional MHRA license and announces regulatory milestones

• MHRA MIA (IMP) license enables international clinical trial
  manufacture and distribution
• EnteroBiotix meets with European Medicines Agency Innovation Task
  Force (ITF) in Amsterdam
• Founding member of Intestinal Microbiome Medicine European Task
  Group (IMM-ETG)

ABERDEEN, Scotland & CAMBRIDGE, Mass.–(BUSINESS WIRE)–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.

Contacts

Nick Freer
+44 (0)7841 571871
[email protected]