Initiation of first multinational study to evaluate safety of OFEV® (nintedanib) with add-on of

• New study explores safety and tolerability of OFEV^® with add-on of pirfenidone versus OFEV^® alone¹
• First multinational study involving 100 patients to investigate add-on treatment with two approved drugs for idiopathic pulmonary fibrosis (IPF)¹
• OFEV^® slows disease progression with approximately 50% reduction in the decline of lung function across a broad range of IPF patient types*^{2,3,4,5,6,7,8}

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announces the initiation of trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603), a new 12 week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV^® in patients with Idiopathic Pulmonary Fibrosis (IPF).¹ The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12.¹

Dr Christopher Corsico, Corporate Senior Vice President Medicine and Chief Medical Officer at Boehringer Ingelheim, commented “The safety and wellbeing of patients is at the centre of everything we do. We are initiating this trial to ensure that we provide the scientific community with important information regarding OFEV^® combination therapy. This trial is part of our continued commitment to tackling the global burden of progressive fibrotic lung diseases.”

IPF is a rare condition that causes thickening and scarring of the lung tissue over time, a process known as fibrosis.^9,10 This fibrosis limits the amount of oxygen that can be delivered to the major organs and also causes difficulty breathing.¹⁰ The median survival of IPF patients following diagnosis is just 2-3 years¹¹, underlining the importance of early and accurate diagnosis and the vital role of treatments that can help to slow disease progression.

“With the publication in July 2015 of the updated international evidence-based guideline for IPF, we now have conditional recommendations for the use of two approved treatment options for patients with IPF; nintedanib and pirfenidone.” said Prof. Carlo Vancheri of the Regional Centre for Rare Lung Diseases, Catania, Italy.

“However, there has been limited evidence to date to establish the safety of combining these treatments. This new trial will provide essential information regarding the safety of adding pirfenidone to core treatment with nintedanib, and could help guide future therapy decisions in IPF.”

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Please click on the link below for ‘Additional information’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/14_december_2015_ipf.html

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