Qureight, a techbio company advancing the understanding of lung and heart disease through application of its AI-powered imaging and clinical data curation platform, today announced that it has been selected by Calluna Pharma to support its Phase 2 AURORA study. Qureight will analyse imaging data from adult patients, evaluating anatomical lung changes in individuals treated with CAL101, Calluna's lead asset for the treatment of idiopathic pulmonary fibrosis (IPF).
The ability to precisely and rapidly assess the efficacy of a promising novel therapy is particularly important for diseases such as IPF, where there are limited treatment options available and the development of new therapies is hindered by the complexities of diagnosis, monitoring and development pathways. Qureight's 3D image-based AI tools will be used to quantify changes in multiple imaging biomarkers, as well as changes in fibrosis volume in localised sections of the lungs, with high sensitivity and precision. These data will provide insights into treatment efficacy through monitoring disease stabilisation or progression. The Qureight platform is able to generate immediate results from these highly detailed analyses, enabling faster and more efficient clinical development compared to traditional image-based analysis of clinical data, which is often challenging and inaccurate.
AURORA is a randomised, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with IPF. The study aims to enrol 150 individuals with IPF across more than 50 sites, primarily in the US, UK, EU, Turkey and South Korea. After an initial 28-day screening period, patients will be randomised to receive seven monthly intravenous infusions of CAL101 or placebo at a ratio of 3:2, respectively. The study's primary endpoint is lung function, measured by forced vital capacity, or how much air can forcibly be exhaled, versus an individual's baseline.
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."
Steven Bishop, Chief Data Officer, Qureight
Jonas Hallén, MD, PhD, Co-Founder and Chief Medical Officer, Calluna Pharma, added: "The recently announced dosing of a first patient in our Phase 2 AURORA study,1 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."
How the Vutara VXL simplifies single-molecule imaging