First Patient Enrolled in Trial of Ofev for Progressive Fibrosing Interstitial Lung Disease


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Boehringer Ingelheim has enrolled the first patient with progressive fibrosing interstitial lung disease (PF-ILD) in a clinical trial that will evaluate the safety and effectiveness of Ofev (nintedanib) for treating the condition.

The double-blind, randomized, placebo-controlled, Phase 3 clinical trial (NCT02999178) will run for 52 weeks. It will be global, and the plan is to enroll 600 patients.

The study’s primary yardstick will be whether Ofev can slow patients’ rate of decline in a lung function measure known as forced vital capacity. Other yardsticks, or endpoints, will include additional measures of lung function and whether Ofev improves patients’ quality of life.

Patients with ILDs, also called diffuse parenchymal lung diseases, can find themselves unable to breathe. The problem stems from impaired gas exchange — a consequence of inflammation or fibrosis in the lungs’ alveolar walls.

There are more than 200 ILD conditions. One is PF-ILD, which applies to patients who exhibit progressive fibrosing, or scarring.

The disease progression in PF-ILD is similar to that in idiopathic pulmonary fibrosis (IPF): worsening respiratory symptoms, lung function, and quality of life, and early death despite treatment.

“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,” Kevin Flaherty, the coordinating principal investigator of the 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 lung is treated and whether nintedanib could be an effective therapy.”

The U.S. Food and Drug Administration (FDA) approved Ofev as an IPF therapy in October 2014. It was one of the first IPF treatments, and is still the only kinase inhibitor, to win approval. The FDA based its decision on trial clinical data showing that the drug slowed IPF progression. The yardstick the trial investigators used to make that determination was annual rate of decline in lung function.

Ofev has yet to be approved for PF-ILD patients because its safety and effectiveness have not been proven in that population. The Phase 3 trial will assess whether Ofev can slow scarring in PF-ILDs’ patients lungs, as it did in IPF patients.

“Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist,” said Christopher Corsico, 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.”

For more information about the trial, including how to participate, please visit this link.


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