ALK's Grazax in five-year landmark asthma prevention trial in children sees mixed results

Denmark-based allergy specialist ALK Abello (ALKB: DC) has announced disappointing 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 five–12 years at the start of the treatment phase. 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.

Secondary endpoint met