Boehringer Ingelheim completes enrollment in nintedanib Phase III trials for IPF

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 INPULSIS^TM 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.

"Boehringer Ingelheim is committed to research in areas of unmet medical need, regardless of how many patients are affected. We strive to improve the lives of patients with idiopathic pulmonary fibrosis," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Nintedanib^* has shown promising results in a Phase II clinical trial and we are optimistic that the drug will further demonstrate its potential benefit in this devastating disease in the ongoing Phase III studies."

The primary endpoint of the two Phase III trials is the annual rate of decline in forced vital capacity (FVC) over a treatment period of 52 weeks in approximately 1,000 enrolled patients. Secondary endpoints include change from baseline in quality of life, time to first acute exacerbation, respiratory mortality, overall survival and on-treatment survival.   

The trials are being carried out in 23 countries in Europe, the Americas, Asia and Australia.

The Phase III trials aim to build upon the promising results of the Phase II TOMORROW trial, which demonstrated a positive trend in reducing lung function decline in IPF patients treated with 150 mg of nintedanib twice daily when compared to placebo.