The immunogenicity results are spectacular within a sub-group of patients allergic to grass pollen studies show, for the first time, the mechanism of action of immunoregulatory remarkable and revolutionary-induced gp-ASIT+.
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This mechanism of action is associated with a clinical effect impressive of gp-ASIT+ in this sub-group of patients who have been exposed to a high concentration of grass pollen.
Knowledge of the mechanism of action is the foundation for the rational design of future products ASIT+. It reduces the risk of future developments of gp-ASIT+, but also the entire portfolio of products ASIT+.
The preparation of the next phase III study with gp-ASIT+ is in progress.
Brussels, Belgium, on 3 July 2017, 7: 00 am (CEST) ASIT biotech (Euronext : ASIT – BE0974289218), a biopharmaceutical company focused on the belgian stage of the clinical development specialized in the research, development and future commercialization of a new generation of immunotherapy products innovative for the treatment of allergies, presented at the conference 2017 of the EAACI (European Academy of Allergology and Clinical Immunology, Helsinki, finland, 17-21 June), in the framework of a session of oral entitled: “Immunotherapy in allergic mechanisms and vaccines “, the immunogenicity results of its phase III clinical study with gp-ASIT+. This communication, which confirms the clinical findings presented by Professor Ralph Mösges at a previous session of Congress, is available on the website (www.asitbiotech.com) of the Company.
In accordance with the protocol developed upstream of this phase III study, all patients recruited to the Ghent University Hospital (n=21 gp-ASIT+; n=11 placebo) gave blood samples to allow the Doctor Shamji, Scientific Advisor of ASIT Biotech and associate Professor at Imperial College London to study the mechanism of action of gp-ASIT+.
Dr. Shamji has presented the results of immunological spectacular, confirming the induction by gp-ASIT+ mechanism of action of immunoregulatory remarkable and revolutionary. The short-term treatment with gp-ASIT+ inhibits radically two mechanisms at the origin of allergic symptoms : (1) the production of specific IgE antibodies to grass pollen and (2) the basophil activation by grass pollen. In addition, a treatment of 3 weeks with gp-ASIT+ induces the production by B cells regulatory protective levels of antibodies blocking the formation of complex between IgE and allergens of grass pollen, this production of antibodies is associated with a clinical effect dramatically during the pollen season.
Indeed, in the context of a strong pollen season in Belgium, have been observed, within this sub-group of patients, significant reductions to the combined score of clinical symptoms and drug intake (-35,1% during the peak pollen and -53,7% for the entire duration of the pollen season) and the score of symptoms of rhinoconjunctivitis (-27,4% during the peak pollen and -56,9% for the entire duration of the pollen season).
Dr. Mohamed Shamji said : “I am excited by the results of our phase III study, which revealed that gp-ASIT+ induces a mechanism of immunoregulation innovative. The immunogenicity observed confirms the clinical efficacy as well as the beneficial effects of the immune regulation induced by gp-ASIT+. I am firmly convinced that the short-term treatment with gp-ASIT+ will have a crucial impact on the way in which the allergic patients will be supported in the future. ”
Thierry Legon, managing director (CEO) of ASIT biotech, comments : “We consider that these phase III results confirm that a subcutaneous treatment for short-term We consider that these phase III results confirm that a subcutaneous treatment for short-term with gp-ASIT+ is the future of allergen immunotherapy for rhinitis to grass pollen. Our determination to put gp-ASIT+ on the market remains complete, and we are already at work to prepare for the next phase III study, with the objective of a start-up before the next pollen season. The discovery of the mechanism of action of gp-ASIT+ is a major milestone for the Company, which confirms for the first time in the world to observe the relevance of immunotherapy using peptide allergens. Knowledge of the mechanism of action of our product minimizes the risks associated with the further development of gp-ASIT+, but also other products ASIT+, in particular those targeting the food allergies, which are now at the preclinical stage, and for which we have adequate funding, thanks to the 6 Million received from the walloon government. ”
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About gp-ASIT+
The candidate product gp-ASIT+ for the treatment of rhinitis to grass pollen is a mixture of fragments of natural allergen obtained from a protein extract specific purified from the pollen of Lolium perenne. As opposed to peptides, synthetic peptides, natural (70% of fragments having a molecular weight of between 1000
