A twice-daily pill significantly raised sputum eosinophil counts and reduced eosinophilic airway inflammation in a Phase 2 trial of asthma patients, according to a study published August 5, 2016 in The Lancet Respiratory Medicine. It also significantly decreased patient-reported asthma symptoms and improved lung function.
The drug, fevipiprant, is a prostaglandin D2 receptor 2 antagonist developed by Novartis Pharmaceuticals. If approved, it would be the first new asthma pill in nearly 20 years.
“A unique feature of this study was how it included measurements of symptoms, lung function using breathing tests, sampling of the airway wall, and CT scans of the chest to give a complete picture of how the new drug works,” said the study’s co-senior author Christopher Brightling, PhD, Clinical Professor in Respiratory Medicine at the University of Leicester, in Leicester, UK.
“Most treatments might improve some of these features of disease,” Dr. Brightling added. “But with fevipiprant, improvements were seen with all of the types of tests.”
For this trial, Dr. Brightling and colleagues recruited 61 adult patients who had persistent, moderate-to-severe asthma and an elevated sputum eosinophil count despite treatment with high-dose inhaled corticosteroids. The researchers randomly assigned half of the patients to receive 225mg of fevipiprant twice a day and the other half of participants to receive a placebo. Patients also continued with their conventional treatment.
After 12 weeks, patients taking fevipiprant showed a reduction in sputum eosinophil percentage from an average of 5.4% at baseline to 1.1% at the end of the trial. Subjects on fevipiprant also showed a reduction of eosinophilic inflammation in bronchial mucosa.
Compared with placebo, fevipiprant also significantly improved patients’ quality of life scores, post-bronchodilator forced expiratory volume (at 1 second), and functional residual capacity, the researchers found. The drug also appeared to be safe and well tolerated.
“We already know that using treatments to target eosinophilic airway inflammation can substantially reduce asthma attacks,” Dr. Brightling said. “This new treatment, fevipiprant, could likewise help to stop preventable asthma attacks, reduce hospital admissions, and improve day-to-day symptoms—making it a ‘game changer’ for future treatment.”
Upon the release of the results, Samantha Walker, PhD, Director of Research and Policy at Asthma UK, said: “This research shows massive promise and should be greeted with cautious optimism.”
“In general, the possibility of one day taking a pill instead of using an inhaler will be a very welcome one” for the millions of people who suffer from asthma, Dr. Walker added.
“More research is needed and we’re a long way off seeing a pill for asthma being made available over the pharmacy counter, but it’s an exciting development and one which, in the long term, could offer a real alternative to current treatments,” she predicted.
Novartis Pharmaceuticals, AirPROM project, and the UK National Institute for Health Research funded this trial.