The US Food and Drug Administration (FDA) has accepted Cumberland Pharmaceuticals’ Investigational New Drug (IND) application for a phase 2 trial evaluating ifetroban for the treatment of idiopathic pulmonary fibrosis (IPF).
“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, chief executive officer at Cumberland Pharmaceuticals.
“Given the exciting preclinical data demonstrating ifetroban can prevent lung fibrosis, we are very excited to advance directly to a phase 2 study for IPF patients.”
Cumberland Pharmaceuticals will launch FIGHTING FIBROSIS™—the multicenter, double-blind, placebo-controlled phase 2 trial that will investigate the safety, tolerability, and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF.
Read more about IPF therapies
Approximately 128 patients with IPF will be recruited across the US. Participants will be block randomized by background therapy (pirfenidone or nintedanib) and assigned to the ifetroban or placebo group (daily dose, 250 mg).
The primary objective is to improve lung function, as measured by the forced vital capacity in patients with IPF on ifetroban versus placebo over 52 weeks.
Ifetroban is a potent and selective antagonist of the thromboxane-prostanoid receptor. In addition, ifetroban has also demonstrated antiplatelet, antivasospastic, antifibrotic, and antibronchospastic activities. Its effectiveness has been shown in preclinical models of vasospasm, thrombosis, reperfusion injury, cardiac fibrosis, lung fibrosis, and endothelial dysfunction.
Cumberland Pharmaceuticals has previously received IND clearance from the FDA for several indications, including systemic sclerosis and Duchenne muscular dystrophy. As a result, phase 2 clinical studies are underway for both conditions.
In addition, the FDA awarded Cumberland Pharmaceuticals $1 million in funding under its orphan products grants program to support the FIGHT DMD™ trial—a multicenter, randomized, placebo-controlled phase 2 trial evaluating 2 doses of oral ifetroban to treat DMD-associated cardiomyopathy.
Cumberland Pharmaceuticals announces FDA clearance of IND for new treatment of idiopathic pulmonary fibrosis. News release. Cumberland Pharmaceuticals Inc.; May 23, 2023.