Jerini has completed patient randomization for its second of two pivotal Phase III clinical trials, FAST-2 (For Angioedema Subcutaneous Treatment), of Icatibant for the treatment of hereditary angioedema (HAE). FAST-2 is a multicenter, double-blind trial with a total enrollment of 74 patients in ten European countries and Israel. Jerini previously announced the completion of randomization in its FAST-1 trial, in which 56 patients were treated at clinical sites in the U.S., Canada, Australia, and Argentina.
The studies seek to determine efficacy for symptom relief, as well as safety and tolerability. To date, more than 260 open-label treatments have been administered in both Phase III trials.
Icatibant is a potent and specific peptidomimetic bradykinin B2 receptor antagonist. HAE is a rare genetic disease that can be debilitating, painful and life-threatening and is characterized by recurrent local swelling at three main sites: subcutaneous tissue, the gastrointestinal tract, and the larynx.