Furthermore, the lack of an adjuvant and the use of highly purified natural allergen fragments results in a reduced risk of side effects and unwanted allergic reactions compared with natural . Allergen fragments, unlike whole allergens, are significantly less capable of crosslinking IgE antibodies present on the surface of mast cells. As a result, allergen fragments have an inherently lower risk of triggering rapid degranulation of mast cells and subsequent release of proinflammatory mediators such as histamine.
The mode of action of gp-ASIT+ has been investigated and published in 2019 in the Journal of Allergy and Clinical Immunology (JACI), the most cited peer-reviewed journal in the field of allergy and clinical immunology.
The recently published data were obtained in the framework of the first Phase III clinical study (2016-2017) in collaboration with Imperial College London. As planned before the start of the clinical study, the subset of 32 patients (21 treated and 11 placebo) recruited at the University Hospital Ghent (Belgium) gave blood samples for the study of the mechanism of action of gp-ASIT+™.
The data demonstrated that a short-course treatment (3 weeks) with gp-ASIT+™ is associated with the activation of regulatory immune mechanisms that protect patients against grass pollen allergy. This immunologic effect persisted until the end of the pollen season. Other ex-vivo works of prof. Shamji (Imperial College London) further support these findings and can now use the ASIT+™ immunological signature as a model for selecting additional product candidates for various allergy indications, such as peanuts, cow’s milk and egg whites. As there is currently no reliable preclinical model for screening new active ingredients for allergen immunotherapy, ASIT’s selection method represents a major asset for developing the best product candidates prior to launching clinical trials with substantial costs.