ALK-Abelló’s GT-14 Study Does Not Meet Primary Endpoint

Danish drugmaker ALK-Abelló has completed a Phase III clinical study with its tablet-based immunotherapy for grass pollen allergy.

The GT-14 study enrolled 329 patients. The primary endpoint was the reduction of patients’ allergy symptoms during the grass pollen season.

The majority of patients in both the active and placebo arms did not record an increase in rhinoconjunctivitis symptoms during the grass pollen season, and the trial did not meet its primary endpoint. An analysis in a subset of patients showed a positive clinical effect that is consistent with the results from a European clinical study program, ALK-Abelló said.

Schering-Plough, which signed a development agreement with ALK-Abelló Jan. 2, will start two studies — one in adults, one in children — with the tablets in 2008.