The aim of the study is the optimization of the dose regimen of BM32 to achieve optimal allergen specific blocking immune response in grass pollen allergy patients and thereby maximized protection from allergic symptoms during the pollen season.
The study follows a novel design by linking a combined symptom and medication score recorded with a patient diary with measurement of grass pollen sensitivity in an environmental exposure chamber. The study protocol has been conceived together with the Vienna Challenge Chamber (VCC), which also acts as the study site. Specific IgG immune response against the four major timothy grass pollen allergens Phl p 1, Phl p 2, Phl p 5 and Phl p 6 is the primary outcome measure of the trial.
The study has already enrolled 133 patients and will read out in the fourth quarter of 2016. The results will set BM32 up for progression into phase III registration studies.