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Phase III Study Evaluates Nintedanib (BIBF 1120) in Pulmonary Fibrosis
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., announced on September 26 that enrollment has been completed for two phase III trials evaluating the safety and efficacy of nintedanib (BIBF 1120), an investigational compound, in patients with idiopathic pulmonary fibrosis (IPF).
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% of patients with IPF die within 2 to 5 years after diagnosis.
IPF is characterized by inflammation and scarring (fibrosis) of lung tissue. 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 affects approximately 100,000 Americans.
In June 2011, the FDA granted orphan drug status to nintedanib.
The two global phase III studies are identical in design and are constructed as double-blind, randomized, placebo-controlled trials with a 52-week duration and matching twice-daily 150 mg dosing, inclusion criteria, and endpoints.
The primary endpoint is the annual rate of decline in forced vital capacity (FVC), or the volume of air that is expelled into a spirometer following maximum inhalation. Reductions in FVC are reflected in impaired ventilation capacity of the lungs. Measuring FVC is a part of the examinations conducted in IPF patients and is scientifically accepted for the assessment of IPF treatment effects.
Secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival, and on-treatment survival.
The two studies have enrolled a total of 970 patients in 20 countries.
Nintedanib is an investigational small-molecule tyrosine kinase inhibitor (TKI). The drug targets three growth factors involved in the fibrotic process: vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR). By blocking these signaling pathways, it is hypothesized that nintedanib may have the potential to reduce disease progression in IPF, thereby slowing the decline of lung function.
Nintedanib is also in clinical development and under evaluation as a possible treatment option for cancer, including non–small-cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, and hepatocellular carcinoma.
For more information, visit the Boehringer Ingelheim Web site.