Response to FMT safety alert issued by the FDA

EnteroBiotix is aware of a safety alert issued by the FDA on 13/06/2019 regarding two patients who acquired Extended Spectrum Beta-Lactamase (ESBL)-producing Escherichia coli infections after receiving faecal microbiota transplantation (FMT). In the alert, the FDA state that the faecal microbiota transferred into the patients was derived from a donor that carried the ESBL producing organisms. Sadly, one of these patients was reported to have died as a result of the infection.

In response to this alert, we have reviewed our procedures and current practice against the recommendations made by the FDA and are of the view that the risk of a multi-drug resistant organism (MDRO) being present in any of EnteroBiotix’s products is very low.

The Company’s pathogen screening protocols are already compliant with the recommendations outlined in European and BSG/HIS consensus guidance and in light of this, the Company screens for Extended-spectrum beta-lactamase (ESBL) producing bacteria (including ESBL E.coli) and other drug resistant organisms such as Vancomycin-resistant Enterococcus (VRE) and Carbapenem-resistant Enterobacteriaceae (CRE). All tests are carried out in UKAS accredited laboratories and any positive result would exclude a prospective donor from becoming an active donor and would prevent an ‘active donor’ from donating any further. In the case of an ‘active donor’, if confirmatory testing was to yield a positive result, then EnteroBiotix would reject and destroy any donated material held in stock from that particular donor.

In addition to robust laboratory screening, the Company also screens prospective donors with questions that specifically address risk factors for the acquisition of MDRO’s. Active donors are also screened for risk factors before each donation.

EnteroBiotix is of the view that this tragic event highlights the need for any manufacturer of medicinal products derived from donor material to operate and adhere to appropriate and robust Quality Management Systems. The Company is also of the view that when industrially produced, facilities that manufacture such products should be licensed by a competent authority. EnteroBiotix’s Quality Management System and manufacturing facilities have been inspected and are licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA). EnteroBiotix holds an MHRA ‘Specials’ license, and an MHRA MIA (IMP) license. The Company has also discussed its screening protocols and manufacturing strategy with the European Medicines Agency (EMA) at a meeting with the EMA Innovation Task Force. Finally, any manufacturer and provider of such products has a duty of care to ensure that patients are appropriately informed of the risks associated with receiving a product manufactured using donor material. The Company’s product and patient information leaflets are appropriate in that respect.

As a licensed provider of products that can be used in FMT, EnteroBiotix has forged hospital partnerships in Scotland, England, Wales, Northern Ireland and Ireland. Ongoing management of product safety and quality assurance remains a top priority for the Company as we continue to serve hospitals, clinicians, researchers and patients. Please do not hesitate to contact us if you have any questions or queries relating to product safety.

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.

EnteroBiotix secure 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 and Cambridge, MA, 19 June 2019 – 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 the company 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 competencies. It was set up to ensure coordination across the Agency 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.

EnteroBiotix secures £2m seed extension investment and opens new office in Boston, USA

ABERDEEN, Scotland & CAMBRIDGE, Mass. EnteroBiotix, a leading clinical stage microbiome therapeutics company headquartered in Aberdeen, Scotland, has closed an oversubscribed seed extension investment and is set for international expansion following the opening of a new office in Boston, US.

EnteroBiotix secures £2m seed extension investment, strengthens leadership position in microbiome therapeutics and opens new office in Boston, US. Tweet this

The pre-series A round was led by Scottish angel firm Equity Gap and supported by existing investors the Scottish Investment Bank (the investment arm of Scottish Enterprise), the University of Aberdeen and the Bank Workers Charity. The company welcomed new investment from Barwell Plc, Gabriel, Syndicate Room, Fund Twenty8, NCIMB Limited and SIS Ventures. The new office in Cambridge, Massachusetts is supporting EnteroBiotix’s operations and business development activities in the US.

EnteroBiotix has also launched a strategic collaboration with the University of Glasgow to support translational research focused on identifying and evaluating precision antimicrobials that the company will combine with its whole ecosystem therapeutics to create an entirely novel medicinal product. The collaboration is supported by the Medical Research Council (MRC) Confidence in Concept (CiC) scheme.

Dr James McIlroy MBChB, Founder and President of EnteroBiotix, said: “We are delighted with the support of both existing and new investors as we strengthen our leadership position in the field of microbiome therapeutics. This investment round and our new office in the States enables us to achieve key regulatory, operational and clinical milestones as we continue to develop and advance our product pipeline for the benefit of patients.”

Fraser Lusty, Investment Director at EquityGap, said: “Equity Gap are delighted to provide further investment into EnteroBiotix as they scale up operations, both domestically and internationally, with exciting emerging opportunities for their innovative microbiome solutions.”

Kerry Sharp, Director of the Scottish Investment Bank, said: “SIB is delighted to provide follow on funding alongside existing and new investors in Enterobiotix. This round of investment will fund ongoing scientific advances which will bring significant health benefits to patients as well as support expansion overseas. We look forward to continuing to work with this High Growth Account Managed company to support it in achieving its growth ambitions.”

About EnteroBiotix

  • EnteroBiotix is leveraging the untapped potential of the gut microbiome to develop novel medicinal products that restore health and prevent disease, with a specific focus on drug-resistant bacterial infections and gastrointestinal conditions.
  • The company has raised over £2.5m of seed investment and is using its MHRA-licensed platform capabilities, industry experience and patent pending technology to advance three core product portfolios that build on the science of the medical treatment known as faecal microbiota transplantation (FMT).
  • EnteroBiotix has established a UK/EU wide service to supply minimally manipulated microbiota products on a named patient basis under an MHRA manufacturers ‘specials’ license

EnteroBiotix announces MHRA license approval and strengthened senior management team

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.”

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.

EnteroBiotix unveils major NHS collaboration during visit by Nicola Sturgeon

Aberdeen, Scotland – EnteroBiotix, a privately held Scottish biotechnology company focused on using the body’s own microorganisms to prevent and treat disease, recently welcomed First Minister Nicola Sturgeon and Scotland’s Chief Medical Officer Catherine Calderwood to its pioneering manufacturing facility and laboratories in Aberdeen as the firm progresses towards commercialisation of its products.

EnteroBiotix founder & CEO Dr James McIIroy shows the First Minister Nicola Sturgeon around the EnteroBiotix facilities

Founded in 2017 by recently qualified doctor at the University of Aberdeen, 25-year old Dr James McIlroy, EnteroBiotix develops faecal derived products for patients suffering from diseases associated with bacterial imbalances in the intestinal gut.

The Company’s novel medicinal products build on the clinically proven strategy of faecal microbiota transplantation (FMT). FMT is the process of transferring bacteria from the gut of a healthy donor into the gut of a recipient to restore a healthy balance.

On the occasion of the First Minister’s visit, EnteroBiotix announced a pioneering collaboration with the Academic Health Science Partnership in Tayside and National Health Service to accelerate and catalyse the adoption of its product line by NHS Tayside.

The collaboration will involve clinical studies, a health economic analysis and the development of a business case for use of EnteroBiotix’s advanced products.

EnteroBiotix founder and CEO, Dr. James McIlroy, said: “The facilities and resources now available to us are game-changing for the company and our product pipeline.

“We now have a platform to develop products for patient use and clinical trials and our collaboration with NHS Tayside and the Academic Health Science Partnership gives us an enormous advantage moving forward as we look to establish ourselves as one of the main players in the fast-moving and exciting field of the microbiome.”

First Minister for Scotland, Nicola Sturgeon, said: “Scotland has a thriving life sciences sector that is renowned globally for innovation and its contribution to pioneering treatments for patients with serious medical conditions.

“Scottish companies like EnteroBiotix are testament to this. The research undertaken at this new facility will have a massive impact on future medical treatments for patients both here in Scotland and further afield.

The Scottish Government recognises the importance of creating the right environment to allow innovative companies, such as EnteroBiotix, to prosper and I’m pleased the Scottish Government, through Scottish Enterprise, has provided the support for them to grow.”

Chief Medical Officer for Scotland, Catherine Calderwood, said: “It is vital that new clinical treatments are developed to meet patient needs and EnteroBiotix is a good example of this. I welcome the announcement of their new partnership with NHS Tayside which will help progress this important research further.”

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.

For further information, please contact:

Dr. James McIlroy, CEO

info@enterobiotix.com

EnteroBiotix celebrates success at UK emerging entrepreneur of the year awards

Aberdeen, Scotland – EnteroBiotix, a privately held Scottish biotechnology company focused on using the body’s own microorganisms to prevent and treat disease, today announced that the Company’s CEO, James McIlroy, was awarded the title of ‘Emerging Entrepreneur of the Year’ at the 2017 BQ National Entrepreneur Festival.

Hosted by BQ and powered by Atom Bank, the awards brought together entrepreneurs from across the UK with the challenge of identifying individuals who, in the view of the judges, are part of the next generation of successful entrepreneurs.

The Scottish award was supported by Scottish Institute for Enterprise. CEO Fiona Godsman said:

“Scotland’s historic contribution to innovation both in the UK and the wider world is widely known. We’re very proud of the next generation of Scottish innovators at SIE and we’re very pleased to help showcase some of our brightest new talent on the national stage. The Scottish winner, James McIlroy, is an excellent example of someone using entrepreneurship to solve a real problem. He’s made great strides with EnteroBiotix which has already gained significant traction and investment”

For further information, please see the official article on the BQ Website.

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.

For further information, please contact:

James McIlroy, CEO

info@enterobiotix.com

 www.enterobiotix.com