Qureight, a techbio company advancing the understanding of lung and heart disease through its AI-powered imaging and clinical data platform, has been selected by Calluna Pharma to support its Phase 2 AURORA study.

Qureight will analyse imaging data from adult patients with idiopathic pulmonary fibrosis (IPF), evaluating anatomical lung changes in individuals treated with CAL101, Calluna’s lead asset. IPF is a progressive and life-limiting lung disease where tissue becomes scarred and stiff, reducing lung function.

CAL101 is a first-in-class monoclonal antibody that neutralises the S100A4 protein, an upstream driver of multiple pro-fibrotic pathways.

Qureight’s 3D image-based AI tools will be used to quantify changes in imaging biomarkers and fibrosis volume in localised lung sections. The company said the platform can provide immediate and highly detailed analyses, enabling faster and more precise assessment of treatment efficacy compared to traditional imaging methods.

The AURORA study is a randomised, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with IPF. The trial will enrol 150 individuals across more than 50 sites in the US, UK, EU, Turkey and South Korea. After screening, patients will be randomised to receive seven monthly intravenous infusions of CAL101 or placebo at a ratio of 3:2. The primary endpoint is lung function, measured by forced vital capacity.

Steven Bishop, chief data officer, Qureight, said: “We’re delighted that Calluna has chosen to work with us on this next stage of clinical trial for their lead programme. Our deep learning imaging technology is bringing faster and more accurate insights to advance the development of novel therapies for lung conditions where there is significant unmet need. The application of our imaging technology as part of Calluna’s clinical study is testament to the power of our approach to deliver meaningful analyses of efficacy. We look forward to continuing our work with the Calluna team.”

Jonas Hallén, co-founder and chief medical officer, Calluna Pharma, added: “The recently announced dosing of a first patient in our Phase 2 AURORA study marks a significant milestone for Calluna, an important step forward in our effort to develop novel therapies for IPF and other fibrotic and inflammatory disorders. The AURORA study is designed to demonstrate CAL101’s potential to impact lung function decline and Qureight’s imaging technology will offer critical insights as we measure these key outcomes.”