Wednesday, May 24, 2023
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) 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.
Idiopathic Pulmonary Fibrosis (IPF) is the newest clinical program in the pipeline for Cumberland's first new chemical entity: ifetroban – a potent and selective thromboxane receptor antagonist. The Company has designed a Phase II clinical trial to study the safety, tolerability, and efficacy of oral ifetroban in patients with IPF. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
Cumberland previously received IND clearance from the FDA for several indications including Systemic Sclerosis and Duchenne Muscular Dystrophy. Phase II clinical studies in patients with those conditions are well underway.
"We are pleased that the FDA has cleared this new clinical program as we work to develop new medicines for the future – especially those that address unmet medical needs," said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "Given the exciting preclinical data demonstrating ifetroban can prevent lung fibrosis, we are very excited to advance directly to a Phase II study for IPF patients."