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Stallergenes, the European pharmaceutical giant, has reported very positive results from a new phase IIb/III clinical trial for of their sublingual immunotherapy tablet for allergic rhinitis caused by birch pollen. This study is the first ever to use a recombinant allergen as an active substance. The study, conducted during the 2009 pollen season, included 483 adult patients allergic to birch pollen and suffering from rhinoconjunctivitis symptoms in 30 centres 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 and one group receiving placebo. The 3 treated groups demonstrated a statistically significant reduction of approximately 25% in symptoms over the season in comparison with placebo group. The overall tolerance was very good, notably for the 12.5 microgram and 25 microgram dosages. This was the first time that clinical development with a regulatory objective had 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 precede application for a licensing agreement. First Published November 2009 |
