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.
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.