Stallergenes S.A. today announced the first results of a phase III clinical trial (VO61.08) conducted in the USA on its sublingual grass pollen immunotherapy tablet, Oralair(R).
This phase III study is the first clinical study in the USA to be conducted by Stallergenes as part of the Oralair(R) clinical development which already encompassed 4 phase III clinical trials conducted in Europe. This development program has so far included over 2,300 patients. This study is pivotal in the perspective of a market authorization application for Oralair(R) in the USA with an adult indication (BLA).
The VO61.08 study is a randomized, double-blind, placebo-controlled, phase III trial. It included 473 adult patients, aged 18 to 65 years, suffering from grass pollen-induced rhinoconjunctivitis, in 51 centers in the United States. The patients were divided into two arms: one group was treated with Oralair(R) and the other with a placebo. The primary endpoint was the reduction of the "combined score", taking into account symptoms and rescue drugs.
The study achieved its objective on the primary endpoint: the reduction of the combined score obtained by Oralair(R) compared to the placebo is statistically very significant and of a similar magnitude to the results of European studies. The product was very well tolerated.
"We are proud to have conducted this study in the USA and very satisfied with the results obtained which confirm the high level of evidence in support of Oralair(R)" commented Albert Saporta, Chairman and CEO of Stallergenes. "We have passed an important milestone in our strategy for the US market and are actively preparing the registration file with a view to filing a Market Authorization application in early 2011."