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ALK Abello A/S's partner for Japan announces trial results for House Dust Mite SLIT-Tablet


Monday, 16 Jun 2014 03:09am EDT 

Alk Abello A/S:Says partner for Japan, Torii Pharmaceutical Co., Ltd. has completed its second of two Phase II/III trials into ALK's sublingual allergy immunotherapy tablet (SLIT-tablet) for the treatment of house dust mite (HDM)-induced respiratory diseases.Torii initiated the trial in 2012 as a randomised, multi-centre, placebo-controlled, double-blind comparative trial, looking at both the safety and efficacy of the drug in patients with house dust mite-induced allergic asthma.While trial confirmed that treatment was well tolerated by patients, with no new or unexpected findings reported.Says trial did not meet the primary efficacy endpoint of showing a statistically significantly lower risk of moderate to severe asthma exacerbations when compared with patients who received placebo.A parallel trial, investigating the safety and efficacy in HDM-induced allergic rhinitis was successfully completed in March 2014 and met its primary efficacy endpoint.Says Torii will now seek to discuss the trial results, along with relevant supportive documentation from ALK's European development programme, with the Japanese health authorities. Based on the available data.Torii expects to submit a registration application to the authorities within the next six-to-ten months.Torii's two trials were similar in design to ALK's successfully completed European trials. ALK targets a regulatory filing for the house dust mite SLIT-tablet in H2 2014 in Europe.