Stallergenes Announces Positive Clinical Results for Its House Dust Mites Immunotherapy Tablet
Antony (France), 4 May 2012 – Stallergenes S.A (Euronext Paris CAC small) today announced results of a clinical study (VO67.10) of its house dust mites sublingual immunotherapy tablet, conducted in an Environmental Exposure Chamber (EEC).
Study VO67.10, a randomized, double-blind, placebo-controlled, dose ranging trial, evaluated the efficacy and safety of 6 months of treatment with 100 IR, 300 IR, 500 IR house dust mites sublingual immunotherapy tablets in 355 adults with house dust mites related allergic rhinitis.
The study met its primary objective. A clear dose effect was observed across the three active doses, with considerable reduction in allergic rhinitis symptoms observed for the 2 higher doses. The primary efficacy analysis demonstrated that, compared to placebo, treatment with the 500 IR dose resulted in a statistically significant reduction in allergic rhinitis symptoms. Secondary efficacy analyses are ongoing.
“We are pleased with the results of the VO67.10 study. They represent an important step forward for our future clinical development of our house dust mites sublingual immunotherapy tablet in Europe, Japan, and the United States”, indicated Roberto Gradnik, Chief Executive Officer of Stallergenes.
All three doses of house dust mites sublingual tablets were well tolerated confirming the favorable safety profile observed in previous studies.
ABOUT THE VO67.10 STUDY
This was a randomized, double-blind, placebo-controlled, dose ranging trial which assessed the efficacy and safety of three doses of house dust mites sublingual immunotherapy tablets for the treatment of allergic rhinitis in an environmental exposure chamber model. Adults aged 18 to 55 years with a history of house dust mites-associated allergic rhinitis, documented allergen-specific IgE antibodies, and symptoms during the baseline challenge to mites in the exposure unit were eligible for participation.
A total of 355 patients were randomized to receive 6 months of daily treatment with 500 IR, 300 IR or 100 IR house dust mites sublingual immunotherapy tablets or placebo. Efficacy was assessed via changes from baseline in rhinitis total symptom scores during environmental exposure chamber challenges to mites at Month 1, Month 2, Month 4 and Month 6 of the treatment period with the primary endpoint at Month 6.
ABOUT THE ALLERGEN CHALLENGE CHAMBER
The Environmental Exposure Chamber is a specially designed facility that enables study participants to be exposed to relevant allergens in a controlled, indoor setting. In this model, the variability in allergen exposure is reduced compared to that in natural field studies.
Stallergenes is a European biopharmaceutical company dedicated to the treatment of allergy-related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergen immunotherapy. The seventh largest pharmaceutical company in France and the leader in sublingual immunotherapy treatment, Stallergenes devotes almost 20% of its gross turnover to Research & Development and is actively involved in the development of a new therapeutic class, sublingual immunotherapy tablets.
In 2011, the company had a turnover of 235 million Euros, and more than 500,000 patients were treated with Stallergenes products.
Euronext Paris (Compartiment B)
Code ISIN : FR0000065674
Code Reuters : GEN.PA
Code Bloomberg : GEN.FP
Additional information is available at www.stallergenes.com
Forward-looking statements related to Stallergenes
This press release may contain forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are based upon the current beliefs and expectations of Stallergenes’ management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.
Roberto Gradnik, CEO
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Posted: May 2012