September 9, 2014
By Mark Terry, BioSpace.com Breaking News Staff
GlaxoSmithKline recently published the positive clinical trial results in the New England Journal of Medicine for its potential asthma drug, mepolizumab. The data will also be presented at the European Respiratory Society’s International Congress, being held September 6th through 10th in Munich.
The study, run by Elisabeth H. Bel, MD, PhD, from the University of Amsterdam in the Netherlands, compared mepolizumab versus placebo in 135 patients with severe eosinophilic asthma. The studies indicated positive results in the mepolizumab group. Another study, run by Hector G. Ortega, MD, ScD, from GSK in Research Triangle Park, North Carolina, was a double-blind, double-dummy study looking at 576 individuals with recurrent asthma exacerbations and eosinophilic inflammation despite previous treatment with inhaled glucocorticoids. Again, this study found significant reductions in the rate of exacerbations compared to placebo.
Mepolizumab is an anti-interleukin-5 receptor alpha monoclonal antibody. Human interleukin-5 regulates the production and function of eosinophils, which are white blood cells involved in the immune system and allergic and asthmatic reactions. They are also common in chronic obstructive pulmonary disease (COPD). Mepolizumab inhibits interleukin-5, lessening the development and activity of eosinophils.
Both Teva Pharmaceutical Industries Limited and AstraZeneca PLC are working on similar drugs. AstraZeneca recently announced mixed clinical trial results for its anti-interleukin-5 drug, benralizumab, in COPD. Although it did show clinically significant improvement in lung function, there were still serious side effects. Teva recently published positive Phase 3 data for its drug reslizumab. It plans to file for regulatory approval in the beginning of 2015.
GSK is also working on treatments for COPD, announcing the presentation of data at the ERS Congress of studies for the development of Relvar® Ellipta® (fluticasone furoate/vilanterol or FF/VI), which is an inhaled corticosteroid/long-acting beta2 agonist combination. The studies suggested the drugs in combination with Anoro® Ellipta® (umeclidinium/vilanterol or UMEC/VI) caused a decrease in blood eosinophil counts in COPD patients.
In a press release, Neil Barnes, Global Franchise Medical Head, Respiratory, GSK, said, “COPD is a heterogeneous disease and enhancing our understanding of how individual patients respond to different treatments is critical to allow treatment to be tailored to their specific needs, with the ultimate aim of improving outcomes.”
GSK expects to submit applications for mepolizumab for regulatory approval this year. Bel said, “Systemic steroids are frequently prescribed for patients with severe asthma, but can have serious and often irreversible side effects, particularly when used for extended periods of time, so there is tremendous value in investigating alternative treatment options. These data help build our understanding of the potential role of mepolizumab in the management of severe eosinophilic asthma. Its potential to reduce the steroid burden that many patients endure, coupled with patients reporting that they actually feel better, are both important for patients and physicians.”
