ASIT biotech S.A.


Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM Administered Subcutaneously to Hay Fever Patients


Principal Investigator(s): Clinic: Bettina Hauswald - Mechanistic: Mohamed Shamji
Type of Study: Interventional Phase II study. Trial is registered on clinicaltrials.gov with number NCT02156791
Recruiting? no

Funding Body:
Start Date: 16-Aug-2013
Projected End Date:

Publications:






Summary


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 clinical trial in patients suffering from hay fever is the assessment of the safety and clinical tolerability of increasing doses of gpASIT+TM when administered by subcutaneous injections, in order to determine the maximal tolerated dose.

The secondary objectives of this trial are :
- The assessment of the immunogenicity, production of blocking antibodies, monitoring of local and systemic reactions with increasing doses of gpASIT+TM.
- Comparison of the reaction to Conjunctival Provocation Test (CPT) performed before and after treatment?

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.

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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