Boehringer Ingelheim Pharmaceuticals, Inc., recently announced the initiation of a trial to compare the safety, tolerability, and pharmacokinetics of adding pirfenidone (Esbriet) to treatment with OFEV (nintedanib, Boehringer Ingelheim) in patients with idiopathic pulmonary fibrosis (IPF).
IPF, a type of interstitial lung disease affecting the tissue that supports the alveoli in the lungs, is characterized by the inflammation or accumulation of scar tissue (denominated fibrosis), leading to progressive loss of elasticity, failure of proper lung activity, and insufficient oxygenation of the bloodstream and organs. The term idiopathic refers to the unknown causes of its pathogenesis. OFEV, a kinase inhibitor taken orally in the form of capsules, was approved by the FDA in October 2014 for the treatment of IPF. Gastrointestinal side effects are the most frequent adverse events of this therapy.
The Phase 4 clinical trial (ClinicalTrials.gov Identifier: NCT02579603) began recruiting in November 2015 and aims to enroll around 100 patients with a confirmed diagnosis of IPF from 25 study centers in the U.S., Canada, Italy, Germany, France, and the Netherlands. The trial is a randomized 12-week study comparing the safety and tolerability of OFEV with pirfenidone (also an FDA-approved IPF drug) versus OFEV treatment alone. Patients in the monotherapy group will receive OFEV 150 mg twice daily, while patients in the dual therapy group will be administered OFEV 150 mg twice daily combined with pirfenidone (up to a dose of 801 mg, three times daily).
The trial’s primary endpoint is the percentage of patients with gastrointestinal side effects from baseline to week 12, as combination therapy with two IPF drugs might lead to a higher risk of side effects. The efficacy of the two treatments will not be assessed. Secondary endpoints include measurement of circulating OFEV and pirfenidone in the blood to determine if pirfenidone interacts with OFEV, and its influence on the amount of OFEV found in the bloodstream.
Dr. Lisa H. Lancaster, associate professor of the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center, said in a press release, “Last year’s FDA approval of the first two treatment options for IPF, followed shortly by their conditional recommendation in International Treatment Guidelines, represented major accomplishments in treating this devastating disease. At the same time, healthcare providers have limited evidence of the safety of combining these two treatments, and the results from this new trial will provide important information to improve the understanding of how these drugs may be able to be used together.”
For more information about the trial and how to participate, please visit this link.