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COPENHAGEN, Denmark, June 9, 2014 (GLOBE NEWSWIRE) -- Today, ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) has presented key trial results on its new sublingual allergy immunotherapy tablet (SLIT-tablet) for house dust mite (HDM) respiratory allergic diseases at the 2014 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI), in Copenhagen, Denmark.
The ALK HDM SLIT-tablet works by addressing the underlying causes of HDM respiratory allergic diseases. It is the first allergy immunotherapy product with a comprehensive clinical development programme aimed at treating both upper and lower airway manifestations of HDM-induced allergic respiratory diseases (namely allergic rhinitis and allergic asthma, respectively).
Together, the MITRA and MERIT trials involved more than 1,800 patients. The trials form part of the largest clinical development programme in the history of allergy immunotherapy, involving more than 5,000 patients from Europe, North America and Japan.
MITRA trial in allergic asthma
The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate the efficacy and safety of the HDM SLIT-tablet compared to placebo in patients with HDM-induced asthma not fully controlled with medium to high dose inhaled corticosteroid (ICS). The primary endpoint of the trial was reduction in the risk of moderate-to-severe asthma exacerbation during ICS reduction as measured by the time to the first exacerbation.
The MITRA trial met its primary clinical endpoint. Patients who received the dose of 12 SQ-HDM experienced a significant improvement in their asthma control as evident by a 34% reduction in risk of suffering a moderate-to-severe asthma exacerbation during the withdrawal of inhaled corticosteroids.
Furthermore, the risk of patients experiencing nocturnal awakenings due to their asthma was significantly reduced in the observation period immediately preceding as well as after ICS withdrawal with the 12 SQ-HDM dose.
At randomisation, 28% of patients had uncontrolled asthma, according to the Global Initiative for Asthma (GINA) control assessment criteria, despite using medium to high dose ICS. The safety profile for uncontrolled patients was consistent with that of the general population with no increased risk identified. This finding may be of high clinical significance as uncontrolled asthma is considered a contraindication to presently available allergy immunotherapy products.