ASIT biotech S.A.

Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

Principal Investigator(s): Clinic: Jan Ceuppens Mechanistic: Mohamed Shamji
Type of Study: Randomised, doubleblind, placebo-controlled study. Trial is registered on with number NCT01111279.
Recruiting? no

Funding Body:
Start Date: 18-Mar-2010
Projected End Date:



ASIT+TM products are based on allergen fragments with optimal size distribution obtained from natural sources. The gpASIT+TM active principle consist in a very broad panel of epitopes covering all the allergens present in the current immunotherapy products while having a reduced risk of induction of systemic allergic reactions.

The primary objective of this Phase IIa study was the assessment of clinical tolerability and safety of the treatment. The secondary objectives of the study were the assessment of gpASIT+TM impact on the immunological and clinical status of the patients.

The clinical study was conducted at the University Hospital of Leuven (Belgium) by Professor J. Ceuppens. Twenty seven patients with grass pollen induced rhinoconjunctivitis received either placebo, gpASIT+TM alone or gpASIT+TM/Dnak and were followed over the subsequent grass pollen season.

Immunological parameters of the patients and mechanism of action of gpASIT+TM was studies in collaboration with Dr. M. Shamji of the Imperial College London. Particular attention was paid to allergenspecific IgE, IgG, IgG4, IgA antibody concentrations and to the production of blocking antibodies.

Lay Summary

Respiratory allergies have a significant impact on the patients, their family and on the society in general. These affect multiple parameters including quality of life, physical, psychological and social functioning and has important financial consequences. Although there are differences among countries, the incidence and prevalence of respiratory allergies is increasing worldwide. In Europe, the overall prevalence of patients with allergic rhinitis is 23%, while in the United States it is estimated at 22%.

ASIT biotech’s strategy is to develop products to satisfy unmet medical
needs, so the target population of gpASIT+TM are those suffering from moderatetosevere allergic rhinitis. The fact that one third of the patients suffering from moderatesevere allergic rhinitis also have asthma will improve the medicoeconomic impact of gpASIT+TM.

Summary of Findings

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