Cumberland begins Phase II clinical development program of Boxaban to treat AERD

The US Food and Drug Administration (FDA) has already granted clearance for the company’s investigational new drug (IND) submission and Phase II trial associated with Boxaban oral capsule.

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.

About one in 20 asthmatic adults suffer from this disease and it is characterized by sharp increases in inflammatory mediators and platelet activity within the respiratory system.

The company said that ifetroban may interfere with these pathways to modify the disease and provide symptom relief.

Scripps Clinic researcher and lead investigator for the trial Andrew White said: "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."

In 2011, Cumberland acquired the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET).

Vanderbilt University professor of Medicine and Pharmacology John Oates said: "Patients with AERD often have the most severe 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.

"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."

Currently, the company is evaluating ifetroban in an injectable formulation in a Phase II trial in patients with Hepatorenal Syndrome (HRS), a life-threatening condition involving progressive kidney failure.