Boehringer Ingelheim has enrolled its first patient with progressive fibrosing interstitial lung disease (PF-ILD) in a Phase 3 clinical trial investigating the effectiveness and safety of treatment with Ofev (nintedanib).
Patients with ILDs, also called diffuse parenchymal lung diseases, are often unable to breathe. The problem stems from impaired gas exchange — a consequence of inflammation or fibrosis in the lungs’ alveolar walls. There are over 200 ILD diseases, one of which is pulmonary fibrosis ILD (PF-ILD), which applies to patients who exhibit progressive fibrosing or scarring. PF-ILD appears to follow a course similar to idiopathic pulmonary fibrosis (IPF) with worsening of respiratory symptoms, lung function and quality of life.
The randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT02999178) will assess the efficacy and safety of Ofev (150 mg) given twice daily over a course of 52 weeks to up to 600 patients with PF-ILD. The trial, which is currently recruiting patients, will take place at clinical sites in the United States, Canada, Europe, Latin America, China and Japan.
The trial’s primary endpoint is to test whether Ofev can slow patients’ rate of decline in forced vital capacity (a measure of lung function). Other endpoints will include additional measures of lung function and changes in the patient’s quality of life.
“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,” Kevin Flaherty, MD, the trial’s coordinating principal investigator, said in a press release. “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.”
Ofev, an anti-fibrotic medication developed to treat IPF, is manufactured by Boehringer. It was approved by the U.S. Food and Drug Administration (FDA) in October 2014 and by the European Commission in January 2015 to treat IPF. These approvals followed positive data showing that the drug can slow disease progression and reduce the annual rate of lung function decline.
The new Phase 3 clinical trial will assess if Ofev can target lung scarring in patients with other progressive fibrosing ILDs, said the company, whose U.S. subsidiary is based in Ridgefield, Conn.
“Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist,” said Christopher Corsico, MD, the company’s chief medical officer. “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.”