Boehringer Ingelheim Pharmaceuticals, Inc. announced that clinical trial enrollment has completed for two phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120), an investigational compound, in patients with idiopathic pulmonary fibrosis (IPF), being studied at a twice-daily oral dose. There are no approved treatments in the U.S. for IPF, a progressive and severely debilitating lung disease with a high mortality rate: approximately 60 percent of patients with IPF die from the disease within two to five years of diagnosis. IPF is characterized by inflammation and scarring of lung tissue, called fibrosis, and over time, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen. As a result, individuals with IPF experience shortness of breath and often have difficulty participating in everyday physical activities. Research indicates that IPF may affect approximately 100,000 Americans.
In June 2011, the U.S. Food and Drug Administration (FDA) granted nintedanib orphan drug status, which identifies compounds for rare diseases.
"With no FDA-approved treatments, today's standard of IPF care is limited to oxygen therapy and lung transplant for some patients," said Dr. Kevin R. Flaherty, a study investigator and associate professor in the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System. Dr. Flaherty is a paid member of Boehringer Ingelheim's nintedanib clinical trial steering committee. "IPF patients desperately need safe and effective treatments to not only reduce the decline in lung function and eventually decrease mortality, but also to stabilize health-related quality of life and delay or reduce sudden worsening of symptoms, or acute exacerbations. These are hallmarks of IPF and are often times unpredictable and can cause death."