Mitizax: Additional Phase III data
Additional data from the double-blind, European Phase III MITRA (MT-04) trial in 834 patients with house dust mite-induced allergic asthma showed that once-daily HDM AIT for up to 18 months reduced the risk of moderate to severe asthma exacerbations, the primary endpoint, by 31% vs. placebo (HR=0.69, p=0.027). Patients received once-daily placebo or 1 of 2 doses of HDM AIT. All patients received inhaled corticosteroids (ICS) until the last part of the trial, where ICS usage was reduced by 50% for 3 months and then completely withdrawn for another 3 months. Data were presented at the European Academy of Allergy and Clinical Immunology meeting in Copenhagen. MITRA is the second of 2 Phase III trials of the product conducted by ALK-Abello to treat house dust mite-induced respiratory diseases. ALK-Abello reported top-line data from MITRA and the Phase III MERIT (MT-06) trial to treat house dust mite-induced allergic rhinitis last year (see BioCentury, June 24, 2013 & July 15, 2013). ...