Jerini Completes Randomization of Last Patient in Phase III European Clinical Trial (FAST-2) of Icatibant for the Treatment of Hereditary Angioedema
June 7, 2006
• Randomization now complete in both Phase III HAE trials
• A total of 130 patients randomized in FAST-1 and FAST-2 trials
• On track to report top line data in 3Q
• Filing of US and European marketing authorization applications planned for year-end 2006
Berlin, - Jerini AG (FSE:JI4) reported today the randomization of the last patient in its Phase III clinical trial (FAST-2) of Icatibant for the subcutaneous treatment of hereditary angioedema (HAE). FAST-2 is one of two Phase III clinical trials being conducted by Jerini for the treatment of HAE. On April 24, 2006, Jerini announced the completion of randomization in its FAST-1 trial, in which 56 patients were treated at clinical sites in the United States, Canada, Australia, and Argentina.
In the FAST-2 trial, a total of 74 patients were treated in ten European countries and Israel in a double blind study against the comparator tranexamic acid. “This brings us one step closer to our goal of launching Icatibant for patients with HAE,” said Jens Schneider-Mergener, CEO of Jerini. “I especially congratulate our clinical team for their outstanding work and perseverance and look forward to presenting the Phase III top line data in the third quarter.” Patients participating in the FAST-1 and FAST-2 randomization phases are eligible to receive Icatibant in the ongoing open-label study phase. To date, more than 260 open-label treatments have been administered in both Phase III trials.
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. Icatibant’s subcutaneous administration, along with its excellent safety profile demonstrated in clinical studies to date and one-year-stability at room temperature, all offer key advantages to HAE patients. Jerini and its US partner Kos Pharmaceuticals, Inc. plan to market Icatibant in a pre-filled syringe that patients can self-administer at the onset of an HAE attack, enabling them to live a safe and independent life.
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 for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), 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.
About Jerini AG
Jerini AG is a pharmaceutical company based in Berlin, Germany focusing on the discovery and development of peptide-based drugs. Having recognized the potential of peptides as natural starting molecules for drug discovery, the company has developed state-of-the-art technologies to identify and transform peptides into drugs. The company’s lead product, Icatibant, is currently in Phase III clinical trials for the treatment of hereditary angioedema. It is estimated that between 1:10,000 and 1:50,000 people worldwide are affected by this disease. Based on its technology platform, Jerini has established several in-house development programs, which address indications within ophthalmology, oncology, and inflammatory therapeutic areas. The most advanced of these programs targets age-related macular degeneration (AMD), the leading cause of vision loss and blindness in people over the age of 55 in developed countries. Clinical testing with Jerini’s drug candidate JSM 6427 will start in the forth quarter of 2006.
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- Director Investor Relations & Corporate Communications
- Jerini AG
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