Cumberland leveraging Qureight’s deep-learning AI platform for its Phase II FIGHTING FIBROSIS™ clinical trial
Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company with development efforts focused on new products for rare diseases, announced a partnership with Qureight, a Core Imaging Laboratory developing deep-learning image analytics, to enhance the outcome and output of data from Cumberland’s FIGHTING FIBROSIS™ clinical trial. The Phase II study is evaluating Cumberland’s ifetroban product candidate in patients with idiopathic pulmonary fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease. This collaboration aims to address a critical unmet need for the estimated 2 million IPF patients worldwide, who currently have limited treatment options that can effectively halt disease progression. The partnership will utilize Qureight’s advanced, deep-learning image analytics tools for complex lung disease applications to provide deeper insights into treatment efficacy and disease progression in Cumberland’s IPF clinical program.
Under this partnership, Qureight’s AI-driven analytics technologies will be used to quantify changes in multiple imaging biomarkers, using computed tomography (CT) data from FIGHTING FIBROSIS™ study patients. Qureight’s quantitative deep learning-based tools will precisely measure changes in the volume of patients’ fibrotic, vascular and airway lung compartments, allowing a more detailed investigation of ifetroban’s modulation of both lung structure and function. The collaboration leverages Qureight’s expertise in IPF and quantitative imaging biomarkers to support Cumberland’s evaluation of crucial primary and secondary study endpoints.
“We are excited to partner with Qureight as we work to develop a new treatment for patients with IPF – and address that critical unmet medical need,” said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. “Given ifetroban’s promising data demonstrating prevention of lung fibrosis in multiple preclinical models, we believe Qureight’s advanced imaging analysis capabilities will provide crucial insights that could help advance understanding and outputs from our IPF clinical program.”
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Cumberland’s FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study investigating the safety and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF. The study includes both patients on existing antifibrotic therapies and those not currently receiving such treatments, with a primary endpoint focusing on change in forced vital capacity.
“We are thrilled to partner with Cumberland Pharmaceuticals on this important clinical trial,” said Dr. Muhunthan Thillai, Chief Executive Officer at Qureight. “Their innovative approach in treating IPF patients for 12 months at this development stage, allows for a truly meaningful assessment of ifetroban’s efficacy and tolerability – the characteristics of treatment that IPF patients so urgently need. When combined with our AI image analytics technologies, the resulting data has the potential to significantly deepen our understanding of how to quantify treatment effects in this complex and devastating disease.”
“The application of AI-driven quantitative imaging in IPF clinical research marks a significant step forward in how we evaluate treatment response,” said Phil Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. “By enabling precise measurement of changes in fibrotic, vascular and airway compartments of the lung, this approach offers insights beyond what traditional pulmonary function tests can provide—potentially allowing us to accelerate the development of urgently needed therapies for patients with IPF.”
Both Cumberland and Qureight will be attending the upcoming American Thoracic Society International Conference in San Francisco, where the FIGHTING FIBROSIS™ study will be featured in the Clinical Trial Awareness area. This collaborative presence at one of the world’s premier respiratory medicine gatherings underscores the companies’ shared commitment to advancing innovative solutions for patients with pulmonary fibrosis.
Source: PRNewswire