ALK-Abello has unveiled positive top-line results from the first of two Phase III trials of the Danish firm's immunotherapy tablet against house dust mite allergy.
Data from the 992-patient MERIT trial demonstrate that the treatment significantly reduces symptoms and medication use in patients with house dust mite-induced allergic rhinitis. The study also demonstrated that it was well tolerated and had a favourable safety profile; preliminary data will be presented at an allergy conference at the weekend in Milan.
House dust mites are the most common cause of allergy in the world, affecting 90 million people in Europe, North America and Japan, and more than 100 million in China. In Europe’s five largest markets, around 1.25 million people have been diagnosed but just a quarter of these are treated with the existing injection- or drop-based allergy immunotherapy products.
The data will form the basis of a European filing in 2014, but ALK will wait for the outcome of the second Phase III trial, MITRA before the end of the third quarter, before submitting. In North America, partner Merck & Co is getting ready for a Phase III trial to investigate the immunotherapy for the treatment of house dust mite-induced rhinitis/rhinoconjunctivitis.
The partnership with Merck also covers two other allergy immunotherapy tablets for grass and ragweed allergy, respectively. Both are currently under review at the FDA.