Brainomix Partners with TIPAL Trial to Assess Its Novel IPF Biomarker in Lung Disease
The company will apply its cutting-edge AI technology to run a sub-study assessing the value of its novel imaging biomarkers
OXFORD, UK, 8th September 2023 – Brainomix announced today that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its groundbreaking e-Lung platform. The TIPAL trial, funded by the National Institute of Health Research (NIHR) and sponsored by the Norfolk and Norwich University Hospitals (NNUH) NHS Foundation Trust, is a placebo-controlled 52-week multi-centre study that is evaluating the impact of lansoprazole – a commonly prescribed medication for indigestion, heartburn and acid reflux – on patients with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition marked by relentless decline in lung function, but with a variable disease trajectory.
The 298 patients expected to be enrolled in the trial will perform home spirometry tests to measure their forced vital capacity (FVC). Daily assessments taken at baseline and 12 months post-randomisation will be compared to assess the impact of lansoprazole on absolute change in percent predicted FVC. Participants will complete weekly spirometry assessments at home during follow-up.
The Brainomix sub-study will be run in parallel using the Oxford-based company’s e-Lung platform, an AI-powered image processing module and tool that standardizes the quantification of lung fibrosis on High Resolution (HR) CT scans to more accurately identify progressive fibrosis patients. At the core of this platform is a novel imaging biomarker, the weighted reticulovascular (WRV) score, which quantifies the extent of the lung affected by reticulovascular abnormalities, and has been shown to provide superior prognostic value compared with traditional measures. The primary aim of the sub-study is to determine the difference in change (between baseline and 12 months post-randomization) in WRV score between treatment with lansoprazole and placebo.
“We are excited to have the opportunity to collaborate with the TIPAL study group, and to incorporate our pioneering AI technology into a prospective trial to help assess the efficacy of lansoprazole in IPF patients,” noted Dr Peter George, Senior Medical Director at Brainomix and Clinical Lead for ILD at Royal Brompton Hospital in London. “We are highly motivated by the potential to harness our technology in a way that helps to speed up clinical trials, identify more effective drugs, and improve the lives of IPF patients.”
Professor Andrew Wilson, TIPAL Chief Investigator, said “It is great to have the chance to incorporate the cutting-edge CT scanning technology developed by Brainomix into the TIPAL study. Not only will this venture tell whether lansoprazole improves the scarring detected on CT scans, but it will allow us to compare CT scan abnormalities to home-based lung function tests”.
More information about the TIPAL study, the UK’s largest government funded pulmonary fibrosis trial, can be found at https://www.uea.ac.uk/web/groups-and-centres/projects/tipal
This study is funded by the NIHR Health Technology Assessment programme (NIHR127479). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.