Qureight, a leading imaging company specializing in precise endpoints for lung and heart disease clinical trials, has announced a significant collaboration with Contineum Therapeutics, a biopharmaceutical firm focused on inflammatory and fibrotic diseases. Qureight's innovative Fibr8™ quantitative imaging biomarker will serve as a crucial secondary endpoint in Contineum's Phase 2 PROPEL-IPF clinical trial. This trial is designed to evaluate the safety and efficacy of PIPE-791, Contineum's primary drug candidate, for patients suffering from idiopathic pulmonary fibrosis (IPF).
The PROPEL-IPF trial utilizes Forced Vital Capacity (FVC) as its primary endpoint, a well-established measurement of lung function in IPF patients. Complementing this, Qureight's Fibr8™ biomarker, driven by advanced AI technology, quantifies the extent of fibrosis observed in High-Resolution Computed Tomography (HRCT) scans. This dual approach allows for a comprehensive assessment of both physiological lung function and the structural burden of the disease. By integrating these two critical measures, the PROPEL-IPF study seeks to uncover the therapeutic effects of PIPE-791 on lung function and the progression of fibrosis, potentially laying the groundwork for future clinical trials to adopt advanced imaging endpoints.
The PROPEL-IPF (NCT07284459) study is a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial. It aims to enroll approximately 324 IPF patients, who will receive once-daily oral PIPE-791 over 26 weeks. The drug candidate, PIPE-791, specifically targets the lysophosphatidic acid receptor 1 (LPAR1), a molecular pathway that has been clinically validated as relevant in IPF. This targeted approach is expected to offer a more effective treatment strategy for this debilitating condition.
Qureight's commitment to advancing quantitative fibrosis measurements in clinical trials was recently highlighted in a European Respiratory Journal publication. This viewpoint advocated for the inclusion of such measurements alongside traditional physiological endpoints in antifibrotic trials. The PROPEL-IPF trial offers a vital opportunity to put this advocacy into practice by generating prospective data on the correlation between treatment-induced changes in lung fibrosis and pulmonary function. Such findings would bolster the evidence supporting quantitative CT as a sensitive indicator of therapeutic response and further Qureight's long-term objective of achieving formal regulatory approval for imaging biomarkers as standard endpoints in antifibrotic drug development.
Simon Walsh, MD, PhD, Chief Scientific Officer at Qureight, emphasized the significance of this integrated approach, stating that the PROPEL-IPF model, which combines FVC as a functional anchor with direct HRCT fibrosis measurement, is precisely what the field requires. He believes this combination has the potential to reveal whether a therapy effectively slows down both the structural disease process and its subsequent functional impairments.
Timothy Watkins, MD, MSc, Chief Medical Officer at Contineum Therapeutics, also expressed enthusiasm for the collaboration, noting that Qureight's quantitative fibrosis measurement method could provide crucial insights within the PROPEL-IPF study. He highlighted the excitement within Contineum's team to work alongside Qureight's clinical scientists, leveraging this advanced imaging platform to gain lung-specific mechanistic understanding of PIPE-791's effects. Ultimately, he believes this measure could serve as an additional tool to evaluate the impact of PIPE-791 treatment on the underlying fibrotic pathology in IPF.
