Jerini completes randomization in phase 3 clinical trial of Icatibant for hereditary angioedema

By Lisa Kerner

Erie, Pa., April 24 - Jerini AG randomized the last of 56 patients in its phase 3 clinical trial (FAST 1) of Icatibant for the treatment of hereditary angioedema, a debilitating, potentially life-threatening disease characterized by recurring swelling attacks in the hands, feet, face, larynx and abdomen.

The double-blind, placebo-controlled study is being conducted at 26 clinical sites in the United States, Canada, Australia and Latin America.

The company expects to complete the randomization of the European FAST 2 phase 3 trial soon, with top-line results for both studies expected in the third quarter of this year.

Icatibant is a synthetic peptidomimetic that acts as an antagonist to the peptide-hormone bradykinin shown to be responsible for edema formation during hereditary angioedema attacks.

Its subcutaneous administration, proven safety profile and one-year-stability at room temperature are key advantages to hereditary angioedema patients, according to a company news release.

Jerini said its plans to file a marketing authorization application for Icatibant by the end of the year, with product launch expected in 2007. The company's U.S. partner, Kos Pharmaceuticals, Inc., will market Icatibant in a pre-filled syringe.

Icatibant has been granted orphan drug status for the treatment of angioedema by the Food and Drug Administration and the European Medicines Agency, as well as FDA fast-track designation.

Jerini, a pharmaceutical company based in Berlin, Germany, develops peptide-based drugs.

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