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Phase II Study Results Show Angioedema Symptoms Resolve Rapidly With Icatibant

Berlin/Germany, January 13, 2004 - Jerini today announced positive results from its POC phase II study to evaluate its lead compound Icatibant (JE049) for the treatment of acute attacks of hereditary angioedema (HAE). Angioedema symptoms resolved rapidly in all eight patients, and the treatment response was sustained over the whole observation period. Together with the excellent safety of the drug, the study outcome confirms that Icatibant can be of significant benefit for treatment of acute attacks of hereditary angioedema.

In this European trial, a single dose of Icatibant was given intravenously to eight patients with acute angioedema attacks. Icatibant was very well tolerated by all patients. No drug-related adverse events were reported.

Icatibant is a bradykinin (BK) 2 receptor antagonist that in contrast to other agents acts directly on the effects of bradykinin causing rapid symptom relief.

"There is genuine excitement in the medical community for Icatibant, because it has demonstrated clinical efficacy in Phase II clinical trials by an entirely novel mechanism of action" commented Icatibant lead investigator Prof. Konrad Bork, from the Department of Dermatology, Johannes Gutenberg University in Mainz, Germany. “These results confirm previous scientific evidence that bradykinin is a major cause for angioedema symptoms. Administration of a bradykinin antagonist such as Icatibant can be expected to be of great therapeutic benefit in this patient population.”

In order to facilitate treatment of HAE attacks, Jerini is developing a subcutaneous formulation of Icatibant. “Subcutaneous injection of Icatibant allows the patient to self-administer the drug," said Jochen Knolle, Jerini’s Head of R&D. “In this way, angioedema attacks can already be treated at a very early stage.” Jerini expects pivotal registration studies of Icatibant in HAE to start in 2004.

As announced in November 2003, Jerini was granted orphan drug designation for Icatibant for the treatment of angioedema by the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) as well as by the European Agency for the Evaluation of Medicinal Products (EMEA).

The most prominent form of angioedema is the hereditary form. The prevalence of hereditary angioedema (HAE) is believed to be between 1/10,000 and 1/50,000 people worldwide. Hereditary angioedema is caused by an activation of the kallikrein-kinin system and increased bradykinin concentration. During an attack of angioedema, bradykinin levels have been shown to be up to 12-fold higher than normal. HAE is characterized by acute episodic attacks of edema (swelling) in body parts, most notably the hands, feet, face, and abdomen. In the case of an attack that affects the airway passages, HAE can be life threatening. Abdominal attacks are often associated with bouts of severe pain, nausea, and vomiting caused by swelling in the intestinal wall.

Numerous other forms of recurrent angioedema, hereditary or acquired, can be reported. Patients affected by these different forms may also be eligible for treatment with Icatibant.

Icatibant, a synthetic decapeptide (peptidomimetic) with a similar structure to bradykinin (BK), is the most potent of the BK receptor antagonists reported on so far. It has virtually the same affinity to BK receptors as BK itself, and a good stability after in vivo administration. Icatibant has exhibited an excellent safety profile in over 700 subjects. It has been successfully tested in several pharmacological models where elevated BK potentially plays a significant role. With BK being one of the most important inducers of attacks of hereditary angioedema, administration of a bradykinin antagonist such as Icatibant is expected to be of therapeutic benefit in this patient population. At present, Icatibant also is tested in a Phase II trial to treat refractory ascites in liver cirrhosis.

Source: Jerini

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