Jerini's Ph III icatibant trial fully randomized

Berlin, Germany-based Jerini AG has randomized the last patient in a Phase III clinical trial of icatibant (FAST 1), its drug candidate for hereditary angioedema. The double-blind, placebo-controlled evaluation includes a total of 56 patients at 26 clinical sites in the USA, Canada, Australia, and Latin America.

Jens Schneider-Mergener, chief executive of the peptide-based drug specialist, said that "we will complete the randomization of the European FAST 2 Phase III trial shortly and continue to be on track to report top-line results for both studies in the third quarter of this year."

Patients participating in the randomization phase of both FAST trials are eligible to receive the drug in the ongoing open-label study phase and filing of a marketing authorization application for HAE is planned for the end of the year, with a product launch expected in 2007, Jerini stated.