[removed]Boehringer Ingelheim Pharmaceuticals Inc[/removed] 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.
In June 2011, the U.S. Food and Drug Administration (FDA) granted nintedanib orphan drug status.
The two global phase III studies are identical in design, 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. Measuring FVC is a part of the examinations conducted in IPF patients and is scientifically accepted for assessment of IPF treatment effects. Secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival, and on-treatment survival.
The trials have enrolled a total of 970 patients in 20 countries. The first patients entered the trials in April and May 2011, respectively.
Source: Boehringer Ingelheim Pharmaceuticals Inc