Mitizax meets endpoint in two Phase III trials for Dust Mite Allergy - ALK
ALK has presented trial results on Mitizax (sublingual allergy immunotherapy tablet or SLIT-tablet) for House Dust Mite (HDM) respiratory Allergic diseases. The MITRA trial (MT-04) evaluated 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 MITRA trial met its primary clinical endpoint - a reduction in the risk of moderate-to-severe asthma exacerbation during ICS reduction as measured by the time to the first exacerbation. 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.
The MERIT trial evaluated the efficacy and safety of the HDM SLIT-tablet compared to placebo in the treatment of HDM-induced Allergic Rhinitis. The MERIT trial met its primary clinical endpoint - a reduction in the combined rhinitis symptom and medication score. The median combined Rhinitis symptom and medication score was reduced by 22% in patients treated with the 12 SQ-HDM dose versus placebo. Furthermore, patients experienced significantly fewer days with Rhinitis exacerbation. The risk of Rhinitis exacerbation was halved, equating on average to approximately 20 fewer days annually with severe rhinitis symptoms. Results demonstrated an onset of action with the 12 SQ-HDM dose as early as 8 to 14 weeks post initiation of treatment.
Both the MITRA and MERIT trials also demonstrated that the treatment was well tolerated and had a favourable safety profile. Based on these findings, ALK expects to submit a regulatory filing to the European authorities in the second half of 2014. Data were presented at the 2014 Annual Congress of the European Academy of Allergy and Clinical Immunology.
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