STALLERGENES opens a new way in the development of second generation desensitisation treatments

With an R&D budget currently represents more than 15% of sales, STALLERGENES has set up a strategy aiming at developping innovative and efficent treatments. In that respect, R&D teams have been reinforced with new competences.

The development programme for sublingual desensitisation tablets

This program is a major project for STALLERGENES and represents significant progress in terms of treatment for patients suffering from allergic respiratory diseases. It consists of developing and marketing a sublingual desensitisation tablet as a pharmaceutical registered drug.

The sublingual desensitisation tablet program includes three products, indicated for the treatment of allergic rhinitis caused by the most common allergens:

Grasses tablet for sublingual desensitisation The Grasses tablet for sublingual desensitisation, for which efficacy and tolerance have been validated by the results of a Phase IIb/III clinical trial involving more than 600 patients and completed in 2005.
This product is in the process of being registered with the German authorities. There will then be a Mutual Recognition Procedure for registration in most other European countries. The clinical development of the Grasses tablet will continue in 2007 with the launch of two clinical studies:
- A long-term efficacy study initiated in Europe and Canada, which will enable determination of the effect of the tablet after treatment has been completed;
- A Phase III paediatric study, conducted in Europe, with the objective of widening the indications of the allergen tablets to allergic rhinitis in children caused by grass pollens.

Bet v 1 tablet for sublingual desensitisation The Bet v 1 tablet for sublingual desensitisation (major allergen of birch pollen) is the first desensitisation tablet developed from an allergen obtained by genetic engineering. This approach enables the production of fully characterised and quantifiable products. The purity and stability of recombinant allergens guarantees perfect reproducibility at a consistent level of quality.
Having demonstrated in 2005 with a multicenter European study that the Bet v 1 recombinant allergen was as effective as natural birch pollen extract and purified Bet v 1, STALLERGENES launched the clinical development of this product in 2007 and is currently carrying out a Phase I study in Denmark.

Mites tablet for sublingual desensitisation The desensitisation tablet indicated for the treatment of allergy to mites , is made up of a mixture of allergenic extracts of D. pteronyssinus and D. farinae, which are the cause of this condition in most European patients. Following the results of the Phase I trial carried out in 2005, demonstrating good tolerance of this Mites tablet, a Phase II/III trial with adults will start in 2007. This large-scale trial, involving more than 600 patients, will be conducted in 10 European countries. In parallel, a Phase II/III paediatric clinical trial is planned for 2009, which will enable validation of the tolerance and efficacy of the Mites tablet in children.

 
At the same time as the development program for sublingual desensitisation tablets, STALLERGENES' Research and Development teams are carrying out an ambitious project for the design of a second-generation therapy.

The objective is to develop a sublingual desensitisation tablet for mites allergies that is even more effective, enabling more rapid action with reduced doses.

The combination of molecular biology techniques and formulation/adjuvant strategies enables better targeting of the immune system of the sublingual mucosa and improvement of the efficacy of desensitisation treatments. The "Enhanced Allergens" programme is based on this concept.

 
The desired active principle is a combination of the major allergens, D. pteronyssinus, Der p 1 and Der p 2, expressed as a single recombinant molecule. This active principle will be formulated so as to increase contact time with the sublingual mucosa and better present the allergen to the target cells of the immune system.

An adjuvant may be associated in order to modulate the quality of the specific immune response to the allergen. An initial candidate product was selected in January 2007 and will undergo pharmaceutical and preclinical development.

In the context of a Proof of Concept trial planned in 2009, several candidate products will be tested in parallel in order to identify the final prototype in 2010. This will then enter a traditional clinical development phase.

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