ABERDEEN, Scotland–EnteroBiotix, a leading clinical stage microbiome therapeutics company, has been granted a manufacturers ‘specials’ license from the Medicines and Healthcare Products Regulatory Agency (MHRA) to further its therapeutic and product pipeline.
EnteroBiotix has also appointed senior biotechnology executive Dr James Clark PhD as CEO, with founder Dr James McIIroy moving to the role of Chief Business Officer in order to support the new CEO and accommodate NHS hospital requirements to complete his medical training as a clinician.
James Clark brings over 20 years of biotechnology and biopharmaceutical drug discovery, development and commercialisation experience to EnteroBiotix. Previous roles have included Chief Technical Officer at Enterome, one of Europe’s leading microbiome companies, and most recently Vice-President of clinical laboratory operations at Inivata, the global clinical cancer genomics group.
Dr James McIlroy, EnteroBiotix founder and Chief Business Officer said: “We are absolutely thrilled to welcome James Clark to the team at this critical inflection point for the business. With the MHRA approval under our belt and a strengthened senior management team, we are well positioned to make an outsized impact in this exciting field of science and medicine. I am grateful to our Board and shareholders for allowing me to continue my NHS medical training alongside my continuing role at EnteroBiotix.”
Dr James Clark PhD, EnteroBiotix CEO, said: “EnteroBiotix is one the most exciting early stage biopharmaceutical startups in the UK, and is attracting significant investor interest. It’s a great time to lead the company and I look forward to working with James and the rest of the team as we enter the next phase of growth.”
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.