Pilot clinical study on the beta prototype of GlyHealth-IBD – a prognostic and predictive biomarker for inflammatory bowel disease (IBD)

Study code
NBR 158

Lead researcher
Daryl L. Fernandes

Study type
Samples and data

Institution or company
Avenna Ltd and Ludger Ltd

Speciality area
Gastroenterology

Summary

This study will be conducted by two sister medical technology companies, Avenna Ltd and Ludger Ltd, based in Oxfordshire, UK. The project is our next step for the translation of GlyHealth-IBD – an in vitro diagnostic (IVD) system we are developing to monitor and predict the health trajectories of patients living with inflammatory bowel disease (IBD).

Currently, clinicians identify the right medication for IBD patients largely through trial-and-error – so patients typically try many drugs before one is found that controls their disease properly. Even then, patients may experience a later worsening of symptoms (‘a flare’). GlyHealth-IBD addresses the unmet need for a test that could predict which treatments would be best for each patient at the point of diagnosis. The technology works by detecting unusual biomolecular patterns in immune components of patients blood that correlate with IBD-related inflammation.

The biomolecules we measure are ‘glycans’ (which are very complex sugar-like structures that modify immune system functions) and the intricate molecular motifs they form are termed ‘glycomics patterns’. The glycomics patterns we measure in GlyHealth-IBD are early-warning, sub-clinical ‘prodromal signals’ of future IBD flares. Our preliminary studies indicate that GlyHealth-IBD can, from a small (0.2ml) sample of blood, reliably measure:

The severity of a patient’s disease now

The likely future course of their disease

The likelihood they would need stronger drugs up to 18 months in the future.

Ludger developed the glycomics technology used in GlyHealth-IBD and Avenna is developing Avenna-IBD - a precision medicine pathway that includes GlyHealth-IBD for tracking and predicting flares. We are now preparing for detailed clinical studies to assess whether or not GlyHealth-IBD would aid treatment selection for newly-diagnosed IBD patients by gastroenterologists. This project is a small initial study to develop clinical and data workflows that we will use in subsequent, larger studies.