Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Stallergenes S.A. announces the results of a phase III clinical trial (VO55.06) conducted in China aimed at assessing the efficacy and safety of sublingual immunotherapy (Staloral(R) mites 300) in adult patients suffering from asthma triggered by house dust mites.

Study VO55.06 is a phase III randomized, double-blind, placebo-controlled study conducted over a period of 15 months in 14 centers located in China's main cities. After an observation period of 3 months, 484 adult patients with mild to moderate asthma well controlled under inhaled corticosteroid therapy were divided into two groups, one treated with Staloral(R) 300 and one given a placebo for a period of 12 months. Throughout the duration of the study, the patients received inhaled corticosteroid therapy at gradually reduced dosages. The patients were assessed on the basis of the level of asthma control as defined by GINA.

Staloral(R) 300 demonstrated statistically significant efficacy versus placebo for the control of asthma, on the basis of the following criteria: "well-controlled asthma" and "totally controlled asthma" in GINA 3 patients (moderate asthma stabilized with corticosteroids by bronchial route). In this population, the probability of a patient having his/her asthma well or totally controlled is more than twice as high with Staloral(R) 300 as it is in the placebo group (odds ratios and 95% confidence intervals of 2.10 [1.01; 4.36] and 2.43 [1.28; 4.61] respectively).

The treatment was well tolerated. There were no pulmonary side effects related to worsening of asthma or deterioration in lung function.

"We are very pleased with the outstanding outcomes of this large-scale study, conducted in China with a solid methodology. They pave the way for better asthma management and improved quality of life for patients", emphasizes Prof. YIN Jia, Principal Coordinator and Head of the Allergy Department at the Peking Union Medical College Hospital and President of the Chinese Allergology Society.

"For the first time, the efficacy of sublingual allergen immunotherapy has been demonstrated in the stabilization of allergic asthma due to mites in adults through a large-scale clinical trial. This very good outcome will enable us to apply for registration of Staloral(R) mites 300 in China in the near future. Obviously, these results will lead the clinical development program for Actair(R), our sublingual immunotherapy tablet for the treatment of allergic rhinitis triggered by dust mites, to also focus on the treatment of asthma in patients allergic to mites", adds Albert Saporta, Chairman and CEO of Stallergenes.