-- On track to report top-line Phase III results in mid-2006 -- Over 350 patients screened in 63 active sites worldwide -- 153 open-label attacks treated in Phase III trials
BERLIN, March 6, 2006 (PRIMEZONE) -- Jerini AG (FSE:J14) announced today 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 (AAAAI) on March 4, 2006 in Miami, Florida. 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 U.S. 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. "Enrollment is proceeding as planned. We are on track to report Phase III results mid-year and subsequently file for marketing approval in the United States and Europe by the end of 2006," said Jens Schneider-Mergener, CEO of Jerini.
Icatibant has been shown to be safe and well tolerated in more than 1,100 individuals in current and previous clinical testing. The current 30mg subcutaneous dose has been administered in over 300 treatments with very good tolerability. Some patients have noted mild, local injection site skin reactions (mainly erythema) which did not require treatment, were rapidly reversible, and did not lead to patient dropout. 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, excellent systemic safety demonstrated to date, and one year stability at room temperature offer key advantages to HAE patients. "We are extremely encouraged by the progress of the Phase III trials and are confident that Icatibant can provide patients with a much needed effective and convenient medication, allowing them to control their disease and live a more normal life," stated Schneider-Mergener.
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 (HAE). It is estimated between 1:10,000 and 1:50,000 people worldwide are affected with 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 mid-2006.