Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced an expansion of its pipeline with a new Phase II development program. The Company has initiated the clinical development of Boxaban™ (ifetroban) oral capsule for the treatment of aspirin-exacerbated respiratory disease (AERD). Cumberland has completed manufacturing and received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) submission and Phase II study associated with the product.
"Physicians and patients alike are eager for viable new treatment options for AERD to help relieve symptoms and restore quality of life. This ifetroban clinical program is a truly exciting development, supported by laboratory findings in animal models of the disease," said Andrew White, M.D., lead investigator for the trial and researcher from Scripps Clinic in San Diego, CA.
Aspirin-exacerbated respiratory disease (AERD), also known as Samter's Triad, is a respiratory disease involving chronic asthma and nasal polyposis that is worsened by aspirin or nonsteroidal anti-inflammatory drugs. Approximately one in 20 asthmatic adults (nearly 1 million patients in the United States) suffer from AERD and the disease awareness is growing within the medical community. AERD is characterized by sharp increases in inflammatory mediators and platelet activity within the respiratory system. Ifetroban, an active thromboxane receptor antagonist, may interfere with these pathways to modify the disease and provide symptom relief. Current treatment of AERD remains a challenge, as novel and effective treatment modalities are lacking for this unmet medical need.
"Patients with AERD often have the most sever and difficult to treat form of asthma. The manufacture of the oral capsule formulation and initiation of the AERD clinical development program by Cumberland represents a significant milestone for our collaboration," said John Oates, M.D., the Professor of Medicine and Pharmacology at Vanderbilt University. "Data from this important trial will help us to understand the potential for ifetroban in treating AERD while generating safety information that will allow us to consider ifetroban therapy for other patient populations."
In 2011, Cumberland announced the acquisition of the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Cumberland is also currently studying ifetroban in an injectable formulation in a Phase II study in patients with Hepatorenal Syndrome (HRS), a life-threatening condition involving progressive kidney failure.
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