Building a Pipeline
of Differentiated Medical Products
Pipeline Products
Phase 2
Dyscorban®
Dyscorban® (ifetroban) oral capsule is being developed by Cumberland for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Preclinical studies demonstrated that ifetroban improved cardiac function, reduced cardiac fibrosis and increased survival in multiple animal models. These encouraging findings compelled us to initiate a clinical program to evaluate ifetroban for the treatment of DMD cardiomyopathy. Following clearance of our Investigational New Drug (IND) application by the FDA, we launched a multicenter Phase II study. Enrollment in the study is complete and we announced positive top-line results, with ifetroban meeting the primary efficacy endpoint and with no serious adverse events associated with our drug noted. Completion of data analysis and a full study report are underway in preparation for a meeting with the FDA to determine next steps for the product’s development and commercialization.
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 decreased mobility, resulting in wheelchair dependency. DMD is the most common childhood muscle disease. Cardiomyopathy is the leading cause of death in these DMD patients – and with no effective treatment, this condition remains an unmet medical need.
The FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for ifetroban for the treatment of cardiomyopathy associated with DMD.
Phase 2
Ifetroban
Ifetroban oral capsule is being developed by Cumberland for the treatment of idiopathic pulmonary fibrosis (IPF), the most common form of progressive pulmonary fibrosis. Following FDA clearance of our IND application, a Phase II clinical study is underway in IPF patients in centers of excellence across the U.S.
Preclinical studies using three models of lung fibrosis demonstrate ifetroban as a promising therapy to investigate with the goal of improving outcomes in patients with IPF. Currently approved therapies for IPF slow the decline in lung function, however they do not provide a long-term cure by halting or reversing disease progression. Additionally, their use is associated with significant side effects, limiting their clinical application for IPF patients. Therefore, there remains a critical need for tolerable and effective therapeutics to treat IPF. Cumberland aims to determine whether oral ifetroban, as an additive to currently approved medications, is a more effective combination therapy compared to matching placebo in patients with IPF.
Phase 2
Vasculan®
Vasculan® (ifetroban) oral capsule is being developed by Cumberland for the treatment of systemic sclerosis (SSc), also known as scleroderma. It is a rare autoimmune disorder that results in a thickening of the skin and internal organs. With pulmonary disease emerging as the major cause of death in SSc patients, preclinical studies have found that ifetroban can prevent cardiac and lung fibrosis. With FDA clearance of our IND, a Phase II study in SSc patients was launched and patient enrollment is now nearing completion.
SSc affects 2.5 million people worldwide and does not yet have a proven curative therapy. Although several medications that suppress the immune system are used to slow progression of the disease, there is no universally effective treatment to improve the function of affected internal organs. Hence the treatment of SSc remains an unmet medical need.