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Following this first year which demonstrated positive results for boththe dosages tested (300 IR[1] and 500 IR) and which is key for the marketingauthorization application, the second year of the study involved anexploratory evaluation of the persistence of the therapeutic effect ofActair(R) in the following year. Out of the 509 patients originally includedin the study, 397 participated until the end of the second year. The primaryendpoint for this second year was the Average Adjusted Symptom Score(AAdSS)[2] measured one year after the end of treatment.
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The results of this second year demonstrate not only that the efficacy ofActair(R) persists well beyond the first six months after treatment isstopped but also that the size effect is globally equivalent to that observedin the first year. Thus in the main assessment period for the efficacyendpoint (between 10 and 12 months after the discontinuation of treatment),both active groups demonstrated a persistent effect of the treatment, with astatistically significant difference for the AAdSS versus placebo [(p=0.0342)for the 300 IR dosage; (p=0.0229) for the 500 IR dosage], still with nodifference between the two treated groups.
This study is a world first in that, for the first time, it indisputablydemonstrates the persistence of the effect of sublingual allergenimmunotherapy in perennial allergic rhinitis triggered by house dust mites,as well as the early onset of this effect, from the end of the first year.The duration and the dynamics of this effect will have to be explored.
"We're clearly delighted with these results. For the first time ever, thepersistence of the therapeutic effect of allergen immunotherapy has beendemonstrated after only a year. This is yet another illustration of thecontribution that the large-scale studies conducted as part of the Stalair(R)clinical development program can make to our understanding of allergenimmunotherapy", says Albert Saporta, Chairman and CEO of Stallergenes. "Likethe trial conducted in asthma triggered by house dust mites with Staloral(R)300 in China, this study will help us construct a development plan forActair(R) that is ambitious in terms of the indications envisaged andrealistic, proposing discontinuous protocols that meet the expectations ofboth patients and health system paying authorities."
ABOUT ALLERGIC RHINITIS TRIGGERED BY HOUSE DUST MITES
In Europe, almost 40% of allergic respiratory diseases, on average, aretriggered by house dust mites, making this the leading cause of respiratoryallergy, ahead of grass pollens. Dust mites are responsible for allergicrhinitis that begins in early childhood, gradually worsens over time andnaturally progresses to asthma. These conditions have marked symptoms thatsignificantly impair patients' quality of life.
ABOUT STALAIR(R)
Stalair(R) is the name of the pharmaceutical and clinical developmentprogram for immunotherapy tablets being implemented by Stallergenes with aview to obtaining market authorizations for pharmaceutical products in Europeand in other strategic markets.
Oralair(R) is the first project resulting from this program. A MutualRecognition Procedure has been completed in Europe. Having recentlydemonstrated its efficacy after 3 years of treatment (study VO53.06 conductedin Europe), Oralair(R) has been the subject of a positive phase III trial inadults in the United States (VO61.08).
The second project in the program is Actair(R), dust mite immunotherapytablet. Following the results of the first year of the phase IIb/III study inallergic rhinitis in adults, a phase III pediatric study has been launched.
The Stalair(R) r Bet v 1 tablet (birch pollen recombinant allergen) hasbeen the subject of a positive phase IIb/III clinical trial conducted inallergic rhinitis caused by birch pollen. A confirmatory phase III study iscurrently being prepared with a view to EMA registration.
The other allergens concerned by the program are ragweed pollen for theNorth American market and Japanese cedar pollen for the Japanese market.Altogether, the program covers 80% of the epidemiology for all markets.
ABOUT STALORAL(R) 300
Staloral(R) 300 is a sublingual solution of allergen extracts forallergen immunotherapy. It is indicated in the treatment of allergicrhinitis, rhinoconjunctivitis and seasonal or perennial mild to moderateallergic asthma in adults and children over the age of 5 years. Prescribed byallergy specialists, Staloral(R) 300 is particularly aimed at patientssuffering from severe allergic diseases inadequately controlled by the use ofsymptomatic treatments.
In the context of a phase III clinical trial (VO55.06) conducted inChina, Staloral(R) 300 has demonstrated its efficacy in the control of asthmatriggered by house dust mites on the basis of "well-controlled asthma" and"total asthma control" criteria in adult GINA 3 patients (moderate asthmastabilized by inhaled corticosteroids).
ABOUT STALLERGENES
Stallergenes is a European biopharmaceutical company dedicated toimmunotherapy treatments for the prevention and treatment of allergy-relatedrespiratory diseases, such as allergic rhinoconjunctivitis, rhinitis andasthma. Stallergenes is the seventh-ranked French pharmaceutical company. Apioneer and leader in sublingual immunotherapy treatments, Stallergenesdevotes more than 20% of its turnover, in gross terms, to Research andDevelopment and is actively involved in the development of a new therapeuticclass: sublingual immunotherapy tablets. In 2009, Stallergenes had a turnoverof 193 million euros and more than 500,000 patients were treated withStallergenes immunotherapy products.
[1] Reactivity index for standardized extracts
[2] AAdSS: Average Adjusted Symptom Score taking into account the totaldaily rhinoconjunctivitis symptom score and recourse to authorized rescuetreatments.Euronext Paris (Compartment B) SBF 120. ISIN code: FR0000065674 Reuters code: GEN.PA Bloomberg code: GEN.FP Additional information is available at: http://www.stallergenes.com
SOURCE Stallergenes
