SIRIUS II trial

September 05, 2005

The European Society of Cardiology (ESC) today highlighted results of a Phase II clinical study of ularitide, a synthetic form of a natriuretic peptide synthesized in the kidney for patients with acute decompensated congestive heart failure (ADHF). The data were presented in the "Hot Line I" session on Heart Failure/Cardiac Function during the ESC's annual congress, the largest cardiology meeting in Europe, held September 3-7 in Stockholm, Sweden.

"Results of the SIRIUS II study show ularitide to be well-tolerated and indicate clear, dose-dependent favorable hemodynamic effects and improvements in cardiac output and dyspnea or shortness of breath. Kidney function was also preserved during the three day observation period following treatment with ularitide," said Veselin Mitrovic, M.D., Medical Director of the Research Unit/Kerckhoff Clinic, Bad Nauheim. "Based on the collective findings, ularitide holds significant potential to address unmet needs in management of ADHF." The SIRIUS II trial was a randomized, double-blind, placebo-controlled clinical trial conducted at 19 centres in Europe. Primary endpoints in the study were change in pulmonary capillary wedge pressure (PCWP) and change in dyspnea score, both at six hours. A total of 221 patients were randomized equally to receive ularitide 7.5, 15, or 30 ng/kg/min given intravenously as a 24-hour infusion, or placebo.

Assessment of the primary endpoints showed ularitide significantly improved dyspnea score (p<0.05) in all three dosing groups compared to placebo. Hemodynamic results from the study showed a significant decrease in systemic vascular resistance at six hours that produced an increase in cardiac index was observed in the 15 and 30 ng/kg/min groups. Additional findings to be explored in further studies include a lower length of hospital stay in the 15 and 30 ng/kg/min groups, compared with the placebo, and no increase in mortality in the treatment group compared to placebo.

The main adverse events through day three were dose-dependent decreases in blood pressure compared to placebo. Serum creatinine levels, which are a measure of kidney function, were unchanged during and after ularitide treatment when compared to placebo. The incidence of serious adverse events was similar between all treatment groups and the placebo group.

The SIRIUS II clinical trial was conducted by CardioPep Pharma GmbH. Protein Design Labs, Inc. (PDL) is leading further development and commercialization of ularitide and has development and marketing rights for ularitide worldwide.

About ularitide
Ularitide is a synthetic form of the naturally occurring natriuretic peptide, urodilatin, and is produced in the kidney where it regulates fluid balance and sodium homeostasis. Ularitide is excreted into the urine, and thus does not exist in the systemic blood circulation. The peptide was first isolated by scientists affiliated with the group of Wolf-Georg Forssmann at Heidelberg University, and has been developed by a German company, CardioPep Pharma GmbH.

In a previous Phase IIa study in patients with ADHF, referred to as the SIRIUS I trial, ularitide was shown to have beneficial hemodyanmic effects (i.e. decrease in PCWP) and improved dyspnea. The SIRIUS I trial was a double-blind, placebo-controlled ascending-dose study. This trial enrolled 24 patients who received a 24-hour infusion of placebo, or in ascending dose cohorts, 7.5, 15 or 30 ng/kg/min of ularitide. The study was primarily intended to assess safety, but evidence of hemodynamic activity was observed at the two higher dose levels when assessed at six hours. There was no apparent difference in adverse events across the four treatment groups.

About Acute Decompensated Congestive Heart Failure
Heart failure is a serious chronic medical condition in which the heart is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation. In the US, heart failure affects more than 5 million people and is a major contributor to healthcare and hospitalization costs. According to the Study Group on Heart Failure Awareness and Perception in Europe, approximately 14 million people in Europe currently suffer from heart failure, and this number is expected to increase to 30 million by the year 2020.

In the advanced stages of heart failure, the heart is unable to meet the body's demand for oxygen and congestion or fluid retention can occur in the lungs or other areas throughout the body. Patients with congestive or decompensated heart failure who come to the emergency room experience what is known as acute decompensated heart failure (ADHF). In the US, heart failure contributes to an estimated one million hospitalizations each year.

ADHF can result from an acute event (e.g. heart attack, acute myocardial infarction). During an acute episode, the inability of the heart to adequately circulate blood throughout the body worsens, kidney function may be diminished and the patient may experience difficulty in breathing.
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European Society of Cardiology

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