ifetroban oral / Cumberland - LARVOL DELTA

CUMBERLAND PHARMACEUTICALS PARTNERS WITH QUREIGHT TO ADVANCE INNOVATIVE IDIOPATHIC PULMONARY FIBROSIS TREATMENT RESEARCH (PRNewswire) - "Cumberland Pharmaceuticals...announced a partnership with Qureight...to enhance the outcome and output of data from Cumberland's FIGHTING FIBROSIS clinical trial....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....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."

Licensing / partnership • Idiopathic Pulmonary Fibrosis

FIGHT DMD Trial Results Selected for Late-Breaking Presentation at MDA Clinical & Scientific Conference (PRNewswire) - P2 | N=48 | FIGHT DMD (NCT03340675) | Sponsor: Cumberland Pharmaceuticals | "Cumberland Pharmaceuticals...today announced that results from its Phase 2 FIGHT DMD clinical trial were selected for a late-breaking presentation at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas....The Phase 2 FIGHT DMD trial demonstrated that high-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo. When compared with propensity-matched natural history controls, the difference was even more pronounced, with high-dose treatment providing a significant 5.4% overall improvement in LVEF, as control patients experienced a 3.6% decline in LVEF....Next steps include further data analysis and completion of a full study report in preparation for an end-of-Phase-2 meeting with the FDA to determine next steps associated with the product's development and commercialization."

Late-breaking abstract • P2 data • Duchenne Muscular Dystrophy

Cumberland Pharmaceuticals Announces Breakthrough Results from the Phase 2 FIGHT DMD Trial in Duchenne Muscular Dystrophy Heart Disease (PRNewswire) - P2 | N=48 | FIGHT DMD (NCT03340675) | Sponsor: Cumberland Pharmaceuticals | "The FIGHT DMD trial (NCT03340675), is a 12-month, double-blind, randomized, placebo-controlled study evaluating ifetroban, an oral thromboxane receptor antagonist. The trial enrolled 41 DMD patients who received either low dose ifetroban (150 mg per day), high dose ifetroban (300 mg per day), or placebo. The study's primary endpoint was an improvement in the heart's left ventricular ejection fractions (LVEF)...Key findings include: High dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF; The high dose ifetroban group showed an increase in 1.8% in LVEF, while the study placebo group showed an expected decline in LVEF of 1.5%; When compared with propensity matched natural history controls, the difference was even more pronounced, with the high dose treatment providing a significant 5.4% overall improvement in LVEF, as the control patients experienced a 3.6% decline in LVEF."

P2 data • Duchenne Muscular Dystrophy

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Cumberland Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Cumberland Pharmaceuticals | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Cumberland Pharmaceuticals | Trial completion date: Apr 2027 ➔ Sep 2026 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

CUMBERLAND PHARMACEUTICALS ANNOUNCES FDA CLEARANCE OF IND FOR NEW TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (PRNewswire) - "Cumberland Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for a Phase II study in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. As a result, Cumberland will launch its FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S."

IND • Trial status • Idiopathic Pulmonary Fibrosis • Respiratory Diseases