CUMBERLAND PHARMACEUTICALS PARTNERS WITH QUREIGHT TO ADVANCE INNOVATIVE IDIOPATHIC PULMONARY FIBROSIS TREATMENT RESEARCH

Rhea-AI Summary

Cumberland Pharmaceuticals (NASDAQ: CPIX) has partnered with Qureight to enhance data analysis in its Phase II FIGHTING FIBROSIS™ clinical trial for idiopathic pulmonary fibrosis (IPF). The trial is evaluating Cumberland's ifetroban product candidate in IPF patients over 52 weeks. Qureight's deep-learning AI platform will analyze CT imaging data to measure changes in patients' fibrotic, vascular, and airway lung compartments.

The multicenter, double-blind, placebo-controlled study aims to address an unmet need for the estimated 2 million IPF patients worldwide. The trial's primary endpoint focuses on changes in forced vital capacity and includes patients both on and off existing antifibrotic therapies. The study is currently actively enrolling at 16 centers out of planned 20+ medical centers across the U.S., targeting 128 patients total.

Positive

• Partnership with Qureight brings advanced AI imaging analytics capabilities to enhance clinical trial data analysis
• Large-scale Phase II trial with 52-week duration allows for meaningful assessment of treatment efficacy
• Study addresses significant market opportunity with 2 million IPF patients worldwide
• Ifetroban showed promising preclinical data in preventing lung fibrosis

Negative

• Trial is still in early Phase II stage with uncertain outcomes
• Significant competition from existing FDA-approved antifibrotic therapies
• Extended 52-week trial duration may impact time to potential market

Insights

Clinical Research Expert

Cumberland's partnership with Qureight adds AI-powered imaging analysis to their Phase II IPF trial, potentially enhancing evaluation of ifetroban's effectiveness.

Cumberland Pharmaceuticals has made a strategic move by partnering with Qureight to incorporate advanced AI imaging analysis into their Phase II FIGHTING FIBROSIS™ clinical trial. This collaboration directly addresses a critical challenge in IPF research: accurately quantifying treatment effects in this complex respiratory disease. Qureight's deep-learning image analytics will measure changes in multiple compartments of the lung (fibrotic, vascular, and airway) using CT data, providing significantly more granular insights than traditional pulmonary function tests alone.

The study design is particularly robust - a multicenter, double-blind, placebo-controlled trial evaluating ifetroban over a full 52-week period. This longer duration enables meaningful assessment of both efficacy and tolerability in a disease where progression typically occurs over months rather than weeks. The trial includes patients both on and off existing antifibrotics, allowing for evaluation across different treatment backgrounds.

What's especially notable is that ifetroban has shown prevention of lung fibrosis in multiple preclinical models. As a thromboxane-prostanoid receptor antagonist with antiplatelet, antivasospastic, antifibrotic, and antibronchospastic properties, its mechanism of action differs from current approved treatments. For the approximately 2 million IPF patients globally who currently lack disease-halting therapies, this represents a potential new pathway for intervention.

The primary endpoint focuses on forced vital capacity (FVC), a well-established measure in IPF trials, but the integration of AI-enhanced imaging biomarkers creates an opportunity to detect more subtle treatment effects that might otherwise be missed. This could potentially accelerate development timelines and provide stronger evidence for regulatory submissions if successful.

Cumberland leveraging Qureight's deep-learning AI platform 
for its Phase II FIGHTING FIBROSIS™ clinical trial

NASHVILLE, Tenn. and CAMBRIDGE, England, May 13, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today 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."

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.

About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. IPF is the most common form of interstitial lung disease and affects up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies.

About The FIGHTING FIBROSIS™ Clinical Trial
The FIGHTING FIBROSIS™ clinical trial is a double-blind, placebo-controlled Phase II study designed to evaluate 12 months of oral ifetroban and enroll 128 patients in over 20 medical centers of excellence across the U.S. The study is currently actively enrolling at 16 centers. The clinical trial is registered on ClinicalTrials.gov under identifier NCT05571059. For more information about the study, including eligibility criteria and participating sites, please visit https://www.fightingfibrosistrial.com/ or contact Ingrid Anderson, PhD at ianderson@cumberlandpharma.com or 615-556-7188.

About Ifetroban
Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Ifetroban also displays anti-platelet, antivasospastic, antifibrotic, and antibronchospastic activities and is effective in certain preclinical models of vasospasm, thrombosis, reperfusion injury, cardiac fibrosis, lung fibrosis and endothelial dysfunction, including models that are insensitive to aspirin. Cumberland acquired the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Cumberland is also sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, and has a Phase II clinical program for Systemic Sclerosis.

About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes:

• Acetadote^® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor^® (ibuprofen) injection, for the treatment of pain and fever;
• Kristalose^® (lactulose) oral, a prescription laxative, for the treatment of constipation;
• Sancuso^® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
• Vaprisol^® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
• Vibativ^® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website: www.cumberlandpharma.com.

About Qureight
Founded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory, a rapidly-scaling techbio company deploying its technology on a global scale. The cloud-based, vendor-agnostic Core Imaging Platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a pulmonologist who trained in lung fibrosis.

Forward-Looking Statements
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

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SOURCE Cumberland Pharmaceuticals Inc.

FAQ

What is the purpose of Cumberland Pharmaceuticals' FIGHTING FIBROSIS clinical trial for CPIX stock?

The Phase II trial evaluates ifetroban's safety and efficacy in treating idiopathic pulmonary fibrosis (IPF) patients over 52 weeks, with the primary endpoint measuring changes in forced vital capacity.

How will Qureight's AI technology benefit Cumberland's CPIX IPF clinical trial?

Qureight's AI platform will analyze CT imaging data to precisely measure changes in patients' fibrotic, vascular, and airway lung compartments, providing deeper insights into treatment efficacy and disease progression.

What is the current enrollment status of Cumberland Pharmaceuticals' (CPIX) Phase II IPF trial?

The trial is actively enrolling at 16 centers out of planned 20+ medical centers across the U.S., aiming to enroll 128 patients total.

What is the market potential for Cumberland Pharmaceuticals' (CPIX) IPF treatment?

The treatment addresses an unmet medical need for approximately 2 million IPF patients worldwide who currently lack treatments that can effectively halt disease progression.

How does ifetroban work in Cumberland Pharmaceuticals' (CPIX) IPF treatment?

Ifetroban is a selective thromboxane-prostanoid receptor antagonist that shows anti-platelet, antivasospastic, antifibrotic, and antibronchospastic activities, demonstrating effectiveness in preclinical models of lung fibrosis.