Cumberland Announces FDA Orphan Drug Grant Award for Ifetroban

Cumberland Pharmaceuticals announced FDA Orphan Drug Grant funding for a new Phase II clinical program. The Company has initiated the clinical development of ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD). Based on pre-clinical findings, the U.S. Food and Drug Administration (FDA) has cleared Cumberland's application to study ifetroban in DMD patients, 7 years of age and older. In addition, Cumberland has been awarded just over $1 million in funding from the FDA through their Orphan Drug Grant program to support a Phase II DMD clinical study. It's the first DMD clinical study approved for FDA Orphan Product Development funding.

DMD is a rare, fatal, genetic neuromuscular disease and is characterized by the progressive loss of muscle which results in deterioration of the skeletal, heart and lung muscles. This deterioration leads to loss of movement and wheelchair dependency. It affects 1 in 3,500–5,000 male children, making it the most common childhood muscle disease. Heart muscle disease is now the leading cause of death in patients with DMD. There is currently no universally effective treatment for the cardiomyopathy associated with DMD, and it remains an unmet need.

"This new program is an excellent strategic fit for our company given our mission to develop new medicines that address unmet medical needs," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "As ifetroban may uniquely address the heart failure associated with this deadly disease, we very much appreciate the FDA grant support of our novel treatment for these critically ill patients."

Ifetroban is a selective and potent thromboxane-prostanoid receptor (TPr) antagonist. Preclinical work on this molecule demonstrated that blocking TPr with ifetroban improves cardiac survival while increasing cardiac output in multiple animal models. These encouraging findings compelled Cumberland to develop a clinical program to evaluate ifetroban for the treatment of DMD cardiomyopathy. The new Orphan Drug grant funding will support a Phase II multicenter study evaluating ifetroban for safety and efficacy in the treatment of DMD heart muscle disease while improving the quality of life in children and men with DMD.

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