Successful Phase III MITRA trial for Dust Mite Allergy

ALK Abello announced positive top-line results from the pivotal Phase III MITRA trial conducted with the allergy immunotherapy tablet against house dust mite-induced respiratory diseases. The results demonstrate that the treatment significantly reduces patients' risks of moderate to severe asthma exacerbations. The results were statistically significant (p<0.05).>

The trial also demonstrated that the treatment was well tolerated and had a favourable safety profile. The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate the efficacy and safety of the allergy immunotherapy tablet compared to placebo in patients with house dust mite-induced asthma. The primary endpoint of the trial was reduction in the risk of moderate to severe asthma exacerbations during steroid reduction as measured by the time to the first exacerbation. The trial was a randomised, placebo-controlled, double-blind, multi-centre trial involving 834 patients from 13 European countries. Patients were divided into three treatment arms. Patients in the first two groups received two different doses of the tablet, while patients in the third group received placebo. Patients were dosed once daily for up to 18 months. Additionally, all patients received treatment with inhaled corticosteroids (ICS) until the last part of the trial, where the ICS usage was reduced by 50% for three months, and then completely withdrawn for another three months. Rights to the product in North America are held by Merck inc.,