Boehringer Ingelheim Phase III study now enrolling patients with progressive fibrosing lung diseases

• For the first time, patients with different fibrosing lung diseases will be included in one single clinical trial assessing the efficacy of nintedanib* as a potential treatment
• The PF-ILD clinical trial is the first in the field of fibrosing lung diseases to group patients based on the clinical behaviour of their disease, rather than the diagnosis
• In total, 600 patients will be included around the world

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstital lung disease) trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis (IPF).¹

There are over 200 conditions that affect the tissue and space around the air sacs of the lungs (interstitium). These conditions are called interstitial lung diseases or ILDs.² Based on clinical obervations there are groups of patients with ILD who independent from the classification of the ILD, exhibit a progressive fibrosing behaviour.^3-6 The proposed terminology for describing this group of patients is PF-ILD. In these patients the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activites, as well as early mortality despite treatment.^3-6

“This trial enrolls patients who have lung fibrosis of at least 10% by chest imaging that is getting worse by symptoms, physiology or imaging despite treatment,” said Kevin Flaherty, Coordinating Principal Investigator of the PF-ILD trial. “This trial is an innovative way to study a potential treatment for patients with progressive fibrosing lung diseases and is an important step in exploring the way fibrosis of the lung is treated and whether nintedanib could be an effective therapy.”

Nintedanib*, which is marketed as OFEV^®, is approved for a rare lung disease called IPF, in which it has been shown to slow disease progression as measured by annual rate of decline in lung function.^7-10 Building on the positive real-world clinical experience in IPF, the Phase III trial is now exploring whether nintedanib can effectively target the scarring in the lungs of patients suffering from other progressive fibrosing-ILDs.

“Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist,” said Dr Christopher Corsico, Chief Medical Officer Boehringer Ingelheim. “Our innovative PF-ILD trial is designed to include patients with fibrosing lung diseases who would not otherwise be eligible to participate in a clinical trial. This demonstrates the commitment of Boehringer Ingelheim to transform fibrosing interstitial lung diseases from fatal diseases to chronic, treatable ones.”

*Nintedanib is currently not approved for use in PF-ILD and its safety and efficacy has not yet been fully established.

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