ANTONY, France, September 16 /PRNewswire-FirstCall/ -- Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by birch pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1.
This study is the first ever to use a recombinant allergen as an active substance. To Stallergenes' knowledge, the use of a recombinant protein in dry form is also a world first.
The VO59.08 study, conducted during the 2009 pollen season, was a randomized, double-blind, placebo-controlled trial. It included 483 adult patients allergic to birch pollen and suffering from rhinoconjunctivitis symptoms in 30 centers in 8 different countries. The patients were divided into 4 groups: 3 groups treated with sublingual tablets containing 12.5 microg, 25 microg and 50 microg of rBet v 1, respectively, with no dose-titration phase, and one group receiving placebo.
The primary endpoint for analysis of the results was the reduction in average adjusted symptom score (AASS). The 3 treated groups demonstrated a statistically significant reduction in AASS in comparison with placebo (0.002<p<0.03) of approximately 25% over the season as a whole and approximately 30% at its peak. The overall tolerance was very good, notably for the 12.5 microg and 25 microg dosages.
"This study conducted by Stallergenes marks a very important milestone in immunotherapy. It is the first time that clinical development with a regulatory objective has been undertaken with a recombinant allergen. Analysis of all the results should make it possible to select the optimum dose and to define the conditions for the confirmatory phase III study that will be conducted with a view to filing a centralized marketing authorization application with the EMEA.
The rBet v 1 program,
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