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.
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, 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.”
1. Press Release (26th August, 2025): Calluna Pharma Announces Initiation of Phase 2 AURORA Study of CAL101 for Idiopathic Pulmonary Fibrosis
For further information, please contact:
For Qureight:
Zyme Communications
Katie Odgaard
Email: katie.odgaard@zymecommunications.com
Tel: +44 (0)7787 502 947
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For Calluna Pharma:
Renate Birkeli
Email: Renate.Birkeli@CallunaPharma.com
Tel: +47 922 61 624
About IPF
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease where an inappropriately activated wound-healing response causes the lung tissue to become thickened and scarred, making it difficult to breathe. The exact triggers of IPF are unknown, but it is believed to be a combination of genetic and environmental factors. Over time, the scarring in the lungs worsens, leading to respiratory failure and ultimately death, with a 3-5 year median survival rate. Primarily found in older adults, the disease impacts approximately 233,000 people in the US and EU.
About Qureight www.qureight.com
Qureight’s AI-powered imaging and clinical data curation platform supports the design of faster, more efficient clinical trials, to significantly accelerate the drug development timeline. Analysing complex patient data, including imaging such as CT scans, outcome measures and blood-based biomarkers from large clinical datasets, Qureight is advancing the understanding of lung and heart disease. Qureight is also enhancing clinical trial design, reducing the need for placebo arms through its Synthetic Control Arms (SCAs), matching patients or ‘digitally twining’ clinical study cohorts using baseline CT scans and fibrosis markers.
Four of the five leading causes of deaths worldwide are due to specific lung or heart diseases. Qureight is actively collaborating with hospitals, pharmaceutical companies and software developers to improve the understanding of lung and heart diseases, the identification of novel biomarkers and endpoints, and to accelerate the development of novel therapeutic approaches.
The Company is formed of a team of globally respected scientists, healthcare specialists and data experts, with a strong history of delivering value to the world’s leading pharmaceutical companies.
Follow Qureight on LinkedIn @Qureight.
About Calluna Pharma www.callunapharma.com
Calluna Pharma is a global clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The Company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases with enhanced efficacy and tolerability.
Calluna Pharma is incorporated in Oslo, Norway and operates globally.