More details

Very positive 3-year results of the long-term study

These results provide confirmation of the clinical relevance of Oralair.

Stallergenes S.A. today announces the 3-year results of a phase III clinical trial (VO53.06) to assess the long-term (sustained) effect and disease modifier effect after discontinuation of treatment of its sublingual grass pollen immunotherapy tablet, Oralair^®. This study is the first ever pivotal study designed to be a long-term and disease modifier trial from the outset.

The VO53.06 study is a randomized, double-blind, placebo-controlled phase III trial conducted over 5 years, 3 years as a pre- and coseasonal treatment regimen and the following 2 years without treatment. It included 633 patients, aged 18 to 50 years, with grass pollen-related allergic rhino-conjunctivitis, in 45 centers in 10 countries. The patients were divided in two treated groups and one placebo group. In the two active arms, there was no dose escalation and the daily dose was a 300 IR sublingual immunotherapy tablet. In one active arm, the treatment started 4 months before the pollen season, and in the other, 2 months before. The total treatment duration for each study-year in all groups was 5 to 6 months up until the end of the pollen season.

The sustained clinical efficacy as defined by EMEA guidelines is the measurement of treatment efficacy after 3 years. The primary endpoint was the Average Adjusted Symptom Score (AASS) .

In the third year analysis, the two treated groups demonstrated a statistically significant reduction of AASS in comparison with placebo (p<0.0001) with a very large effect.

Relative differences versus placebo (season 3)  

A reduction of 40% was achieved in the 2nd year and a reduction of 30% in the 1st year (relative median differences versus placebo). These results not only demonstrate the sustained clinical effect of Oralair^® administered using a pre- and coseasonal treatment regimen but also suggest an increase in efficacy over the seasons.

In addition, each of the six individual symptom scores has demonstrated a statistically significant improvement. All the outcomes obtained in the secondary endpoints were statistically significant and consistent with those of the primary endpoint.

Patient compliance was very satisfactory over the three seasons and the overall tolerance was excellent.

In accordance with the recommendation of a board of independent experts (Data and Safety Monitoring Board), the study will be continued over the next 2 years in order to assess the disease modifier effect (maintenance of therapeutic benefit after treatment discontinuation).

In addition to this long-term study, in 2009 Stallergenes conducted a phase III one-season optimization study (VO60.08) with Oralair^® 300 IR. This randomized, double-blind, placebo-controlled study was performed without dose escalation and used a 2-month pre-seasonal treatment regimen. In this trial, 180 patients were enrolled in each of the two arms. The analysis on the primary endpoint did not reach a statistically significant difference, although positive trends were demonstrated. Further in-depth analyses will be performed, to identify likely methodological bias.

“We are very enthusiastic about the results of the VO53.06 study which far exceed our expectations. We will file for an extension of the product’s current labeling, as defined in the marketing authorization recently obtained via a Mutual Recognition Procedure (MRP) in 23 European countries. Such setbacks due to the VO60.08 study outcome can occur in any large development program, and in no way call into doubt the overall findings of the Oralair^® program as a whole, which remain extremely consistent. The development program, which focuses on the benefit to patients and fits squarely with current cost-containment trends, confirms the relevance of Stallergenes’ strategic choices.
Our 2009 clinical news flow has been very dense and is not over yet. There are still more results to come and more analyses to be conducted. We will be delighted to present all these findings at an R&D day to be held at the start of 2010.” says Albert Saporta, Chairman and CEO of Stallergenes.

EMEA: European Medicines Agency
AASS: Average Adjusted Symptom Score: A score taking into account the daily rhino-conjunctivitis total symptoms score and rescue medication usage.