In just over two years since its inception, EnteroBiotix has advanced from a concept on a piece of paper to a reputable biopharmaceutical company delivering potentially life-saving medicinal products to patients across the UK and EU.
The company was established by Dr James McIlroy in March 2017 to unlock the full therapeutic potential of a medical treatment called faecal microbiota transplantation, also known as FMT.
FMT is a medical treatment used by doctors to restore a healthy balance of bacteria in the gut of a person suffering from a disease or infection associated with bacterial imbalances.
It involves the transfer of rigorously screened intestinal dwelling bacteria derived from the stool from a healthy donor into the intestinal tract of the person suffering from infection.
Clostridioides difficile (C. difficile) is one such bacterium that under certain criteria can cause a disturbance to an individual’s healthy microbiome. It can ultimately lead to an infection that is characterised to a large extent by diarrhoea, cramping and pain, fever and nausea. In the most severe of cases, C. difficile infection can be life threatening or fatal.
Patients with a C. difficile infection can often be successfully treated with antibiotics, however, there is a high risk of the infection returning as the underlying microbial imbalance that allows C. difficile to proliferate remains untreated.
When patients suffer from multiple recurrences, this has a significant impact on both their quality of life and on the NHS.
Medical treatments that restore diversity in the gut microbiome could be the best option for patients suffering from hard-to-treat infections caused by gut-dwelling bacteria.
To date, the most successful of these treatments is FMT, with cure rates of 90% reported widely across the medical literature. Indeed, FMT has been approved by the National Institute of Health and Care Excellence (NICE) for recurrent C. difficile.
What does EnteroBiotix do?
To capitalise on the growing clinical demand for FMT and in response to the evident absence of an off-the-shelf and ready-to use product for use in FMT, EnteroBiotix has established field-leading microbiome collection, manufacturing and distribution capabilities, which include an active donor registry, a controlled stool donation facility and fully integrated Good Manufacturing Practice (GMP) compliant stool processing facilities.
The company holds two regulatory manufacturing licences from the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s executive agency which is responsible for ensuring that medicines work and are acceptably safe.
Collectively, these capabilities and licences have enabled the company to distribute its first-generation novel medicinal products to doctors across the UK and Europe and serve patients with serious unmet clinical needs.
Looking forward, the ambition of the company is now evolving beyond its initial concept.
Indeed, the exponential growth of research into the microbiome has now linked imbalances in the gut microbiome with intestinal diseases, ranging from acute infections caused by C. difficile to more complicated chronic conditions such as inflammatory bowel disease and irritable bowel syndrome.
The impact of imbalances within the gut microbiome may even reach other parts of the body, with studies linking imbalances to diseases of the brain and nervous system such as Parkinson’s, Autism Spectrum Disorder and multiple sclerosis.
In response, the company has quadrupled its workforce, secured several rounds of substantial investment (including one recently for £2 million). It is now actively developing its product pipeline with a view to realising the full therapeutic and clinical potential of its products.
The company’s ongoing commitment to realising both its therapeutic and research ambitions means that it is constantly looking to recruit healthy stool donors to capture healthy bacteria. The company is working hard to dispel the taboo and overcome the obvious mental barrier that can be associated with donating stools.
It has established a tried-and-tested donor screening and donation process that while comprehensive remains simple and easy.
The company would like to hear from individuals who are:
- Over the age of 18
- Generally fit and healthy
- Happy to visit the Rowett Institute at least once a week to donate in a dedicated toilet facility.