House dust mites desensitization tablets: Positive results from a phase IIb/III clinical trial

Release of the first year outcome of the VO 57.07 clinical study on a sublingual house dust mite desensitization tablet.

Stallergenes S.A. announces the release of the first year outcome of its phase IIb/III clinical trial (VO 57.07) on a sublingual house dust mite desensitization tablet.

“We are very pleased with the outcome of this study, which is the first large study to ever demonstrate the efficacy of house dust mites allergen in treating perennial allergic rhinitis. Furthermore, the unexpected quick onset of action and the good safety profile are addressing the needs of patients with moderate to severe forms of the disease. This study will be pivotal in the European registration process of our house dust mites sublingual tablet, and the basis for further developments in our program” states Albert Saporta, Chairman and CEO of Stallergenes. “This study is a genuine landmark which confirms desensitization as a new therapeutic class in the management of allergic respiratory disorders. Stallergenes has been consolidating its leadership in this field through its innovative and development capabilities”.

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Stallergenes has been conducting a phase IIb/III clinical trial, with a sublingual tablet in adults suffering from moderate to severe persistent allergic rhinitis to house dust mites, including 509 patients, over seven countries, with a full year of treatment from January to December 2008. This study compared two treated groups, one with a daily intake of 300 IR*  sublingual tablet, the other of 500 IR, with a placebo group. The endpoint was the adjusted average symptom score on nasal symptoms assessed during the three last months of the year.

The two treated groups have demonstrated a highly significant statistical difference on the primary endpoint versus the placebo group (p0.0136), with no difference between the two treated groups. In the different groups, use of rescue medication was allowed throughout the period. The adjusted average symptom score has been improved by 20% in both treated groups. In particular, the nasal congestion score has been improved by 40% (median) and the nasal pruritus by 32% (median). The safety profile has been highly satisfactory.

For the same level of efficacy, the 300 IR tablet has been selected.

Furthermore, the onset of action was achieved from the 4th month of treatment, meaning that the difference between the placebo and the treated groups was statistically significant, the treatment effect being maintained at the same level up to the end of the study.

The quality of life has been statistically improved and the proportion of symptom-controlled days increased by 52%.

The study will be pursued over 1 year on an observational basis in accordance with protocol. 

“The conduct of clinical trials in perennial allergic rhinitis is a major challenge. The outcomes of the VO57.07 are clearly good and consistent, clinically important and relevant”, said Prof. Karl-Christian Bergmann, international coordinator of the study. “These results are more than promising for the roll-over of the development of house dust mites sublingual desensitization therapy”.

* Index of Reactivity for standardized extracts