ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announces top-line results from the GRAZAX® Asthma Prevention (GAP) trial with ALK’s allergy immunotherapy tablet against grass pollen allergy. The GAP trial consisted of a three-year treatment phase and a two-year follow-up phase and included 812 children aged 5–12 years at the start of the treatment phase. The primary objective was to investigate the effect of GRAZAX® compared with placebo on the risk of developing asthma. The primary endpoint of the trial was time to first diagnosis of reversible impairment of lung function. The hypothesis was that fewer subjects receiving GRAZAX® would get this diagnosis or be diagnosed later than subjects in the placebo group. Within the five year evaluation period there was no detectable effect in terms of time to the first diagnosis of reversible impairment of lung function and hence the primary endpoint of the trial was not met. In contrast, treatment with GRAZAX® had a positive effect on the children’s asthma symptoms and use of asthma medication. The odds ratio (secondary endpoint) for experiencing asthma symptoms[1] or using asthma medication[2], at the end of the five-year evaluation period, was 0.66 (p<0.05) in favour of GRAZAX® treatment. Moreover, the proportion of patients experiencing asthma symptoms or using asthma medication was significantly reduced from year 2 and onwards in the group receiving GRAZAX® treatment compared with the placebo group (with relative risk reductions ranging from 36-50%). The beneficial effect on asthma symptoms and asthma medication use was observed year-round in the two-year follow-up phase. Thus, based on asthma symptoms and asthma medication use, a disease modifying effect was shown that sustained two years after end of treatment. In addition, the GAP trial demonstrated efficacy on grass allergic rhinoconjunctivitis in the three treatment years and in two follow-up years, showing a 23-30% symptom reduction (p<0.005 all five years) in patients receiving GRAZAX® treatment compared with those receiving placebo (secondary endpoint). The level of symptom reduction was in line with previous trial results. All patients had access to symptom-relieving rhinoconjunctivitis medications throughout the five years of the trial. At the end of the trial, the use of this medication was recorded and patients who received GRAZAX® treatment also used significantly less rhinoconjunctivitis medications compared with those receiving placebo (p<0.001). Henrik Jacobi, ALK's Executive Vice President of Research and Development says: "With this particular trial design, we were not able to detect an effect in terms of time to the first diagnosis of reversible impairment of lung function. Nevertheless, we are very encouraged to see a clear and clinically meaningful treatment effect on asthma symptoms and on the use of asthma medication that sustains two years after end of treatment.” He continues: “Furthermore, the trial confirms the disease modifying effect of GRAZAX® on grass pollen allergy in children. Thus, when children are treated with GRAZAX® they will not only have a beneficial effect on their nose and eye symptoms, but also a reduced risk of experiencing asthma symptoms and of using asthma medication in the years following end of treatment." GRAZAX® was approved in Europe in 2006 and is today marketed in all major markets. GRAZAX® is the world’s best documented grass allergy immunotherapy product and has data from 17 randomised, double-blind, placebo-controlled clinical trials, covering more than 5,600 patients providing evidence that GRAZAX® treats symptoms in both adults and children and targets the cause of their allergy. The product was approved in North America in 2014 where it is marketed by ALK’s partner MSD (known as Merck in the USA and Canada) under the brand name GRASTEK®.