Jerini AG presents clinical development update for Icatibant in the treatment of hereditary angioedema
Jerini AG announced that clinical trial progress from its ongoing Phase III clinical trial for hereditary angioedema (HAE) was presented by Dr. Alvin Davis, Harvard Medical School, at the American Academy of Allergy Asthma and immunology Conference Dr. Davis reported that 153 subcutaneous open-label treatments with Icatibant have been administered for abdominal, cutaneous, and laryngeal HAE attacks, with 91 percent of patients being treated with only a single injection within 24 hours. Eight percent of patients received a second injection and one percent received three injections within 24 hours. In the ongoing Phase III trials, patients completing the randomised study phase are eligible to receive Icatibant in the open-label study phase (for ethical reasons, laryngeal attacks, which are potentially life-threatening are only treated in the open-label phase). In addition, 48 percent of participating Phase III patients have been treated with Icatibant in multiple HAE attacks, with one patient receiving more than 30 treatments.
Jerini is conducting two Phase III clinical trials with Icatibant for the treatment of HAE: FAST 1 and FAST 2 (For Angioedema Subcutaneous Treatment). HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, and abdomen. Icatibant has been granted orphan drug status from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of angioedema, potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE. The FAST 1 trial, to treat a total of 56 patients, currently has 31 active sites in five countries including the United States, Canada, Australia, and Latin America. The FAST 2 trial, to treat a total of 74 patients, currently has 32 active sites in 12 countries including Europe and Israel. More than 350 HAE patients have been screened for participation in these studies.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks.
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