Drugstore Blog News

After having announced positive results with regard to the first year of its phase IIb/III clinical trial (VO 57.07) conducted adhering Actair(R) sublingual allergen immunotherapy tablets in allergic rhinitis triggered by habitation dust mites in April 2009, Stallergenes S.A. announces the results of the second year of this study.

Following this first year that demonstrated positive results because far as concerns both the dosages tested (300 IR[1] and 500 IR) and what one. is clew for the marketing authorization application, the further year of the study involved an exploratory evaluation of the persistence of the therapeutic effect of Actair(R) in the following year. Out of the 509 patients originally included in the study, 397 participated until the end of the second year. The primary endpoint for this second year was the Average Adjusted Symptom Score (AAdSS)[2] measured one year after the end of treatment.

The results of this maintainer year demonstrate not simply that the efficacy of Actair(R) persists well beyond the first six months after treatment is stopped further also that the weak glue effect is globally interchangeable to that observed in the first year. Thus in the indispensable tax period for the force endpoint (between 10 and 12 months after the discontinuation of treatment), both active groups demonstrated a persistent effect of the treatment, with a statistically significant difference for the AAdSS versus placebo [(p=0.0342) for the 300 IR dosage; (p=0.0229) for the 500 IR dosage], subdue by in no degree difference between the couple treated groups.

This study is a universe first in that, for the first time, it indisputably demonstrates the persistence of the effect of sublingual allergen immunotherapy in perennial allergic rhinitis triggered by house dust mites, to the degree that healthy as the early storm of this issue, from the end of the first year. The continuation and the dynamics of this general determine have to be explored.

“We’re clearly delighted with these results. For the before anything else time through all ages, the persistence of the therapeutic effect of allergen immunotherapy has been demonstrated after only a year. This is yet another illustration of the contribution that the large-scale studies conducted as part of the Stalair(R) clinical progressive growth program be possible to make to our notion of allergen immunotherapy”, says Albert Saporta, Chairman and CEO of Stallergenes. “Like the trial conducted in asthma triggered by dint of. partnership dust mites with Staloral(R) 300 in China, this cogitate will help us construct a development plan because Actair(R) that is eager for distinction in stipulations of the indications envisaged and realistic, proposing discontinuous protocols that meet the expectations of the pair patients and hale condition plan paying officials.”

ABOUT ALLERGIC RHINITIS TRIGGERED BY HOUSE DUST MITES

In Europe, almost 40% of allergic respiratory diseases, on medial sum, are triggered by house dust mites, composition this the governing cause of respiratory allergy, ahead of grass pollens. Dust mites are responsible towards allergic rhinitis that begins in early childhood, gradually worsens over time and naturally progresses to asthma. These conditions have marked symptoms that significantly impair patients’ rank of the vital spark.

ABOUT STALAIR(R)

Stalair(R) is the name of the pharmaceutical and clinical development program for immunotherapy tablets being implemented by Stallergenes by a view to obtaining place of traffic authorizations for pharmaceutical products in Europe and in other strategic markets.

Oralair(R) is the foremost throw out resulting from this program. A Mutual Recognition Procedure has been completed in Europe. Having recently demonstrated its efficacy following 3 years of handling (do one’s best VO53.06 conducted in Europe), Oralair(R) has been the subject of a confident phase III experimental knowledge in adults in the United States (VO61.08).

The favor project in the program is Actair(R), dust mite immunotherapy tablet. Following the results of the first year of the phase IIb/III study in allergic rhinitis in adults, a phase III pediatric learn has been launched.

The Stalair(R) r Bet v 1 tablet (birch pollen recombinant allergen) has been the expose of a positive phasis IIb/III clinical trial conducted in allergic rhinitis caused by birch pollen. A confirmatory phase III study is currently being prepared through a view to EMA registry.

The other allergens concerned by the program are ragweed pollen for the North American market and Japanese cedar pollen as being the Japanese place of traffic. Altogether, the program covers 80% of the epidemiology toward wholly markets.

ABOUT STALORAL(R) 300

Staloral(R) 300 is a sublingual disunion of allergen extracts for allergen immunotherapy. It is indicated in the treatment of allergic rhinitis, rhinoconjunctivitis and seasonal or perennial clement to moderate allergic asthma in adults and children over the age of 5 years. Prescribed by allergy specialists, Staloral(R) 300 is particularly aimed at patients endurance from accurate allergic diseases inadequately controlled by the use of symptomatic treatments.

In the words immediately preceding of a appearance III clinical action (VO55.06) conducted in China, Staloral(R) 300 has demonstrated its efficacy in the control of asthma triggered by house dust mites on the base of “well-controlled asthma” and “full asthma regulate” criteria in adult GINA 3 patients (moderate asthma stabilized by inhaled corticosteroids).

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical social meeting dedicated to immunotherapy treatments towards the prevention and treatment of allergy-related respiratory diseases, such as allergic rhinoconjunctivitis, rhinitis and asthma. Stallergenes is the seventh-ranked French pharmaceutical company. A pioneer and corypheus in sublingual immunotherapy treatments, Stallergenes devotes in addition than 20% of its turnover, in gross articles of agreement, to Research and Development and is actively involved in the progress to maturity of a new therapeutic class: sublingual immunotherapy tablets. In 2009, Stallergenes had a turnover of 193 very great number euros and again than 500,000 patients were treated with Stallergenes immunotherapy products.

References

[1] Reactivity index with regard to standardized extracts

[2] AAdSS: Average Adjusted Symptom Score taking into account the total daily rhinoconjunctivitis mark register and recourse to authorized rescue treatments.

Source: Stallergenes

Comments are closed.