Qureight's fibrosis imaging biomarker selected by Contineum Therapeutics as a secondary endpoint in Phase 2 PROPEL-IPF clinical trial

Qureight, an end-to-end imaging company providing enterprise-grade imaging and precision endpoints for clinical trials for lung and heart disease, and Contineum Therapeutics, Inc. (Contineum), a clinical-stage biopharmaceutical company pioneering differentiated small molecule therapies for inflammatory and fibrotic diseases with significant unmet need, today announced that Qureight's Fibr8^™ quantitative imaging biomarker is being used as a secondary endpoint in Contineum's PROPEL-IPF Phase 2 clinical trial examining the safety and efficacy of PIPE-791, Contineum's lead drug candidate, in idiopathic pulmonary fibrosis (IPF) patients.

Forced Vital Capacity (FVC), the primary endpoint in PROPEL-IPF, provides an established measure of lung function in IPF patients. Qureight's AI-powered Fibr8^™ imaging biomarker complements FVC by measuring the extent of fibrosis visible on High-Resolution Computed Tomography (HRCT), providing an assessment of structural disease burden. By examining both physiological and quantitative imaging measurements, PROPEL-IPF will investigate treatment effects on both lung function and imaging-defined measures of fibrosis progression, potentially generating valuable evidence to support the development of imaging endpoints for future clinical trials.

PROPEL-IPF (NCT07284459) is a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating the efficacy, safety, and tolerability of once-daily oral PIPE-791 with 26 weeks of treatment in approximately 324 people with IPF. PIPE-791 targets the lysophosphatidic acid receptor 1 (LPAR1), a clinically validated target for IPF.

Qureight recently published a Viewpoint in the European Respiratory Journal advocating for the integration of quantitative fibrosis measurements alongside established physiological endpoints in antifibrotic clinical trials1. PROPEL-IPF represents an important opportunity to try to advance this approach by potentially generating prospective evidence on the relationship between treatment-related changes in lung fibrosis and pulmonary function. This would strengthen the evidence base for quantitative CT as a sensitive measure of therapeutic response and support Qureight's longer-term ambition to pursue formal regulatory qualification of imaging biomarkers as endpoints in antifibrotic drug development.

PROPEL-IPF is a strong example of the endpoint model we believe the field needs: preserve FVC as the functional anchor, while measuring fibrosis directly on HRCT. The combination has the potential to help reveal whether a therapy is slowing the structural disease process as well as its downstream functional consequences."

Simon Walsh, MD, PhD, Chief Scientific Officer, Qureight

Timothy Watkins, MD, MSc, Chief Medical Officer, Contineum Therapeutics, added: "Qureight's approach to quantitatively measure fibrosis could provide important insights in PROPEL-IPF. We are excited for our team to partner with the clinical scientists at Qureight, leveraging this imaging technology platform to enable lung-specific mechanistic insight into the effects of PIPE-791. Ultimately, this measure has the potential to serve as an additional means by which we can assess the impact of PIPE-791 treatment on underlying fibrosis pathology in IPF."