Boehringer Ingelheim completes enrollment in nintedanib Phase III trials for IPF

Published on September 24, 2012 at 4:08 AM · No Comments

Boehringer Ingelheim is pleased to announce the last patients have been randomised into the Phase III sister trials assessing the efficacy and safety of nintedanib (150 mg twice daily) in patients with idiopathic pulmonary fibrosis (IPF). The pivotal INPULSISTM Phase III trials continue as planned in study centres worldwide to assess the clinical outcomes in IPF patients treated with nintedanib.   

"Idiopathic pulmonary fibrosis is a severely debilitating condition which results in a progressive loss of lung function, associated with a clear deterioration in quality of life for our patients," said Luca Richeldi, MD, PhD, lead study author and director of the Research Centre for Rare Lung Diseases, University of Modena and Reggio Emilia, Modena, Italy. "As a treating physician I clearly see the high unmet need for effective new treatments which may substantially change the clinical course of this deadly disease. Modifying the decline in lung function or reducing the rate of acute exacerbations would clearly be crucially important goals."

Acute exacerbations are an unpredictable part of the clinical course of IPF, which can lead to death in one in two patients within a few months, and are in many ways different from exacerbations in other pulmonary disorders. Most importantly, in the absence of infections or alternative causes, patients experience acute worsening of dyspnoea, with evidence of new infiltrates on lung images. IPF is classified as a rare disease by the European Medicines Agency and the US National Institutes of Health with prevalence estimated to range from 14-43 per 100,000. Median survival is 2 to 3 years after diagnosis.   

Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) which targets growth factor receptors, which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis, namely vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). The investigational compound received orphan-drug designation from the U.S. Food and Drug Administration in June 2011 and by the Ministry of Health, Labour and Welfare of Japan in September 2011.

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