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CUMBERLAND PHARMACEUTICALS ANNOUNCES FDA CLEARANCE OF IND FOR NEW TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Cumberland initiating Phase II FIGHTING FIBROSIS™ clinical trial, Newest program in Cumberland's ifetroban pipeline NASHVILLE, Tenn., May 23, 2023
About this update from Cumberland Pharmaceuticals Inc.
[{"type":"text","content":"Cumberland initiating Phase II FIGHTING FIBROSIS™ clinical trial, \nNewest program in Cumberland's ifetroban pipeline\nNASHVILLE, Tenn., May 23, 2023 /PRNewswire/ -- 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.\n\n \n \n \n \n \n \n\n \nIdiopathic 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.\nCumberland 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.\n \"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.\"\nAbout the new Phase II Clinical Trial\nThe FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study in patients with IPF. The study will investigate the safety and efficacy of once daily oral ifetroban for 52 weeks. Subjects will be block randomized by background therapy (pirfenidone or nintedanib) and assigned to one of two treatment groups, ifetroban or placebo, at a dose of 250 mg daily. Approximately 128 subjects with IPF will be enrolled in the U.S. The primary objective is to improve lung function, as measured by the FVC in IPF patients on ifetroban compared ...