Boehringer Ingelheim Pharmaceuticals has enrolled the first patient in its progressive fibrosing interstitial lung disease (PF-ILD) clinical trial, which will investigate the effectiveness and safety of Ofev (nintedanib) in a range of diseases other than idiopathic pulmonary fibrosis (IPF).
The U.S. Food and Drug Administration (FDA) approved Ofev in October 2014 for treating IPF. That made it one of the first approved therapies with demonstrated effectiveness in slowing disease progression in IPF. This new trial is exploring whether Ofev can effectively target scarring in the lungs of patients suffering from other progressive ILDs — conditions that affect the tissue and space around the interstitium, or air sacs of the lungs. More than 200 types of ILDs are known to date.
This is the first time patients with different types of fibrosing lung diseases will be included in one single trial assessing the effectiveness of Ofev as a potential treatment.
Some patients with ILDs other than IPF exhibit progressive fibrosis, regardless of their ILD. In these patients, the disease appears to follow a similar course to IPF, with worsening of respiratory symptoms and lung function, as well as decreased quality of life and difficulty performing daily tasks.
The Phase 3 clinical trial (NCT02999178) will evaluate Ofev 150 mg twice daily throughout the course of 52 weeks in PF-ILD patients.
The study’s primary endpoint is assessing disease progression by measuring the annual decline in forced vital capacity (FVC), a measure of lung function. The trial will also measure the quality of life of PF-ILD patients to assess the impact of treatment. Secondary endpoints include time to first exacerbation and overall survival.
“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, coordinating principal investigator of the PF-ILD trial, 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.”
For the trial, patients will be grouped based on the clinical behavior of their disease, rather than the diagnosis, which is an innovative approach.
Boehringer, based in Ridgefield, Conn., hopes to enroll 600 patients worldwide, including about 60 sites in the United States. The study seeks patients with documented lung scarring as well as proven worsening of lung function and respiratory symptoms despite treatment.
“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,” said Christopher Corsico, MD, chief medical officer at Boehringer. “This demonstrates the commitment of Boehringer Ingelheim to transform fibrosing interstitial lung diseases from fatal diseases to chronic, treatable ones.”