Testing for the effectiveness of biologic treatments of inflammatory bowel diseases: developing a new patient-led product

A diagnostic test to select inflammatory bowel disease treatments

AlphaBiomics is a London-based start-up, with a product in development to improve the clinical care of people with Crohn’s disease or ulcerative colitis. These are both progressive, life-long inflammatory conditions of the bowel, which for some patients can be treated by biologics. Biologics are made by living organisms rather than manufactured from chemicals, and are powerful drugs that may reduce inflammation.

However, they are expensive, and response is highly variable with 15-50% of patients not responding to initial treatment [1]. There is currently no test to predict which patients will respond to biologic drugs. As a result, determining whether a biologic therapy will be effective is a matter of trial and error.

Targeting the UK health service

AlphaBiomics has developed a diagnostic test called RxSelex™ that determines whether a biologic treatment will be effective, in advance of treatment starting. The test analyses a patient stool sample for important bacterial components using next-generation-sequencing. This information is then analysed using a proprietary prediction analysis, which utilises machine learning.

The company chose to launch in the UK first, having initially received product-development funding from NIHR (National Institute for Health and Care Research). They were advised that if they could achieve a recommendation from NICE (National Institute for Health and Care Excellence), then the NHS and other markets could become more easily accessible.

Developing the prediction analysis

The first step was to develop the prediction model, using publicly available data. This was made possible by NIHR Invention for Innovation (i4i) Connect funding, awarded early in 2019. Using the results from this study, they received further i4i funding in early 2020 for algorithm validation, an essential step in diagnostic product development, using real stool samples from current patients.

The team realised early on that they needed to bring in experts to cover certain areas of the work they were undertaking. Marcus says, "While we had extensive experience in pre-clinical research, we had little idea about diagnostics, getting a product to market, or how to involve patients in our idea".

Bringing people into the picture

As part of the first grant programme, the team worked with patient and public involvement (PPI) experts at the Centre for Public Engagement (CPE) at Kingston University in London to set up a small focus group. Marcus says, "It was a very useful experience, listening to people with bowel disease and hearing their stories. At the end of the day, we’re all patients. It helps to go back and think, how would I feel? How would I want this to be communicated?"

For the second product development phase, the CPE, a PPI manager at one of the clinical sites, and a patient co-applicant helped them to set up a Patient Advisory Group. They took part in quarterly meetings, learning about the science behind the product and the aim of the test, and providing feedback based on their lived experience.

This group helped develop a UK-wide patient survey, formulating and adjusting the questions to be user-friendly, and the stool sample collection kit, testing its usability and the clarity of the instructions.

Making connections through the NHS Innovation Service

The connections made so far have included:

• NIHR, for the funding stream and to link with the national NIHR Clinical Research Network lead for gastroenterology about carrying out a clinical utility study across multiple UK sites.
• The new Artificial Intelligence and Digital Regulations Service, which is formed of NICE, MHRA, HRA (Health Research Authority) and Care Quality Commission (CQC). It is an advisory service for developers of AI and other digital technologies in health and social care, and will be key to helping AlphaBiomics deliver their product in the UK.
• NICE, specifically their scientific advisory service, which will be useful in designing a clinical utility study.

"The expertise within the service around who to talk to and the sequence in which to approach different organisations is invaluable, as well as information around PPI, and navigating the funding landscape", says Marcus. "You still have to ask the questions, you still have to do the work, but it’s very helpful to get an idea of who you can talk to in this very complicated network".