European trial results positive for dust mite allergy tablet

The first of 2 pivotal phase 3 trials with a new allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases, has met its primary end points, according to ALK and partner Merck.

The results were highly statistically significant (P<.01). The positive outcome allows for a European filing in 2014.

“The study is the first phase 3 trial of a tablet-based allergy immunotherapy. The tablet is similar to the tablets for treatment of ragweed and grass allergy currently under review by FDA,” said ALK spokesperson Martin Barlebo. “The trial also demonstrated that the treatment was well tolerated and had a favorable safety profile. [ALK and Merck] are preparing a phase 3 trial in North America. The first patients in the study are expected to start treatment toward the end of the year.”

The results of the MERIT trial (MT-06) was initiated by ALK in 2011 to evaluate the efficacy and safety of the allergy immunotherapy tablet versus placebo in the treatment of house dust mite-induced allergic rhinitis.

The primary end point of the trial was a reduction in the combined rhinitis symptom and medication score. The trial was a randomized, placebo-controlled, double-blind, multinational, multicenter trial; 992 patients from 12 European countries were divided into 3 treatment arms of equal size. Patients in the first 2 groups received 2 different doses of the tablet, while patients in the third group received placebo but had unrestricted access to symptom-relieving medication. The patients received treatment once daily for 1 year.

House dust mites are the most common cause of allergy in the world. House dust mite-induced allergy is estimated to affect around 90 million people in Europe, North America, and Japan, and more than 100 million people in China. The condition appears early in life, is present all year round, and patients face an elevated risk of developing asthma and other allergies. In Europe’s 5 largest markets, around 1.25 million people have been diagnosed with persistent moderate-to-severe and uncontrolled house dust mite-induced allergic rhinitis, however, it is estimated that just a quarter of these are treated with the existing injection- or drop-based allergy immunotherapy products.