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
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
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.