Cumberland Pharmaceuticals Collaborates with Qureight on Idiopathic Pulmonary Fibrosis Research

Cumberland Pharmaceuticals Inc., a company specializing in developing treatments for rare diseases, has announced a collaboration with Qureight, a Cambridge-based Core Imaging Laboratory. This partnership aims to enhance the data outcomes of Cumberland's FIGHTING FIBROSIS™ clinical trial, which explores the potential of ifetroban, a drug candidate for idiopathic pulmonary fibrosis (IPF). IPF is the most widespread type of progressive fibrosing interstitial lung disease, affecting around 2 million people globally. Current treatment options provide limited relief, highlighting an urgent need for more effective therapies.

Cumberland's Phase II trial investigates ifetroban's impact over 52 weeks, involving patients with IPF, some of whom are already undergoing antifibrotic therapies. The trial is conducted in a multicenter, double-blind, placebo-controlled format, focusing mainly on changes in forced vital capacity—a key measure of lung function. The collaboration with Qureight is set to leverage advanced AI-driven imaging analytics to provide nuanced insights into the efficacy of the treatment and the progression of the disease. Qureight's platform will be employed to assess modifications in various lung imaging biomarkers, quantifying changes in fibrotic, vascular, and airway compartments through CT scans.

This partnership is expected to provide detailed insights into the structural and functional modulation of the lungs by ifetroban, supporting Cumberland in evaluating vital study endpoints. A.J. Kazimi, CEO of Cumberland Pharmaceuticals, expressed enthusiasm about the collaboration, emphasizing the potential of Qureight's technology to enhance understanding and data output from the clinical program.

Qureight's expertise in IPF and imaging biomarkers will be instrumental in refining the assessment of treatment responses. Dr. Muhunthan Thillai, CEO of Qureight, highlighted the significance of combining Cumberland's innovative approach with their AI tools to deepen understanding of treatment effects in this challenging disease. The AI-driven analytical approach marks a notable advancement in IPF research, offering insights beyond traditional pulmonary function tests, potentially accelerating the development of needed therapies.

The companies plan to present their collaborative efforts at the American Thoracic Society International Conference in San Francisco, emphasizing their commitment to advancing solutions for pulmonary fibrosis patients. The presence at this prestigious event underscores the importance of their work in respiratory medicine.

IPF is characterized by inflammation and fibrosis in the lungs, leading to rapidly declining respiratory function and reduced survival rates within five years of diagnosis. Although some FDA-approved therapies can slow disease progression, no treatment currently halts progression or significantly improves symptoms, creating a demand for new therapeutic options.

The FIGHTING FIBROSIS™ trial is actively enrolling participants across 16 centers, with plans to include 128 patients in over 20 medical centers of excellence nationwide. The study is registered under ClinicalTrials.gov identifier NCT05571059, offering further details on eligibility criteria and participating sites.

Ifetroban, the drug being tested, is a selective antagonist of the thromboxane-prostanoid receptor (TPr), displaying various beneficial activities in preclinical models, including antifibrotic effects. Cumberland developed ifetroban in collaboration with Vanderbilt University and Cumberland Emerging Technologies.

Cumberland Pharmaceuticals, headquartered in Tennessee, is committed to developing products that improve patient care quality across several market segments, including hospital acute care, gastroenterology, and oncology. Their portfolio includes several FDA-approved brands designed to treat various conditions.

Founded in 2018, Qureight is a rapidly expanding techbio company specializing in deep-learning image analytics, providing vendor-neutral solutions for clinical trial data assessment, compliant with various international standards.

This collaboration between Cumberland and Qureight represents a significant step forward in addressing the unmet needs of IPF patients, potentially leading to more effective treatment options that could transform patient outcomes.