“The results of the SIRIUS II study show ularitide to be well-tolerated and indicate clear, dose-dependent favorable effects in treating the symptoms of ADHF without compromising kidney function,” said Dr Veselin Mitrovic, medical director of the Research Unit / Kerckhoff Clinic, Bad Nauheim. “Based on the overall findings, ularitide holds potential as a treatment for ADHF patients.”
The data from the trial were presented at the annual European Society of Cardiology (ESC) Congress, the largest cardiology meeting in Europe, taking place in Stockholm, Sweden.
The trial was a conducted at 19 centers across Europe. 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.
The two primary endpoints in the study were change in dyspnea (shortness of breath) score and change in pulmonary capillary wedge pressure (PCWP), a measurement of lung vessel pressure, at six hours.
Ularitide treatment was associated with a significantly improved dyspnea score in all three dosing groups compared to placebo. Dyspnea was assessed using a standard dyspnea scale, which measures a patient’s perception of their change in shortness of breath from the start of drug therapy. More patients reported moderate to marked improvement in dyspnea in all of the three treatment groups compared to placebo.
The findings also demonstrated a significant decrease in pulmonary pressure as measured by PCWP at six hours. These changes were also associated with an increase in cardiac index (a measure of heart function) in the 15 and 30 ng/kg/min groups. At six hours, PCWP dropped 10-12 mmHg on average from baseline for those treated with ularitide, compared to those on placebo, for whom PCWP dropped 4mmHg from baseline.