Pharma Focus Asia

Boehringer Ingelheim Phase III Study Now Enrolling Patients with Progressive Fibrosing Lung Diseases

Thursday, April 20, 2017

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstitial 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).

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. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. 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 activities, as well as early mortality despite treatment.

"This trial enrolls patients who have lung fibrosis of at least 10 percent by chest imaging that is getting worse by symptoms, physiology or imaging, despite treatment," said Kevin Flaherty, M.D., 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 lungs 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. 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 Christopher Corsico, M.D., 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."

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