Qureight announces world’s first digital biomarker for lung fibrosis will ‘transform’ clinical trials

UK based clinical data analytics company Qureight has announced the world’s first digital biomarker for idiopathic pulmonary fibrosis (IPF) – potentially transforming clinical trials involving complex diseases, as well as treatment decisions for patients.

Presented at the European Respiratory Society meeting in Barcelona, the announcement marks the first time artificial intelligence (AI) using convolutional neural networks has been used to analyse trial data involving the IPF.

The AI-based Lung8 imaging software picked up differences in response between patients who had an experimental drug compared with those who took a placebo – key information that traditional analysis had failed to find, the company noted.

IPF is a condition in which the lungs become scarred and breathing becomes increasingly difficult. It is unclear as to what causes the condition, but it typically affects people who are around 70 to 75 years old. Such scarring can also be a long-term consequence of COVID-19 infection.

IPF is difficult to treat, and monitoring requires complex breathing tests in hospitals, with Qureight outlining that the test has a number of problems and is not always an accurate measure of lung capacity. Despite this, in clinical trials to test new drugs for IPF, breathing tests are currently used as the main measure of deciding whether a new drug is working or not.

In this most recent study, Qureight partnered with Galapagos, which was conducting a phase 2 clinical study to test a new IPF drug – GLPG1205 – in 68 patients affected by the condition.

GLPG1205 resulted in smaller declines in forced vital capacity and total lung volume at week 26 versus the placebo, but the difference was not significant.

However, after the completion of the trial, using Lung8, Qureight was able to show that CT scans over 26 weeks revealed a significant difference in lung volume change between subjects administered GLPG1205 compared to placebo, showing GLPG1205 slows reduction in lung volume over time in IPF.

Qureight chief executive officer Dr Muhunthan Thillai, a lung specialist at Royal Papworth Hospital in Cambridge, said: "Existing clinical trials involving IPF can cost more than $150m per drug study and take at least 12 months to look for breathing changes in patients. Our novel platform technology could halve the duration of trials and therefore significantly reduce the costs involved. This will be invaluable for our pharmaceutical partners as they plan their next set of drug trials for this complex disease.”