Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced efficacy and safety results from a Phase II trial of urocortin 2 in 53 patients with acute decompensated heart failure. The UNICORN study was conducted over approximately a two year period by the Cardioendocrine Research Group from the University of Otago in Christchurch, New Zealand and included patients admitted to Christchurch Hospital with acute decompensated heart failure. After initial stabilization, subjects were randomized to receive a 4-hour infusion of either placebo or urocortin 2 in addition to standard-of-care treatments. Infusion of urocortin 2 was generally well tolerated and there were no treatment-related serious adverse events. There was one heart failure related death, not related to drug, in the urocortin 2 arm of the study that occurred 48-hours post infusion.
The hemodynamic profile of urocortin 2 infusion was consistent with what had been established in earlier Phase I and Phase II clinical studies including improved cardiac output, reduction in peripheral vascular resistance and absence of sympathetic overstimulation. Mean arterial pressures were significantly reduced (p<0.001) from 92 +/- 3 mmHg at baseline to 80+/-3 mmHg at end of the urocortin 2 infusion.
"The result of this Phase II study shows that urocortin 2 is very potent hemodynamically and improves cardiac output over the course of administration," said Christopher F. O'Brien, Chief Medical Officer, Neurocrine Biosciences. "We wish to thank University of Otago cardiologists Drs. Wandy Chan, Richard Troughton, and Mark Richards in Christchurch, New Zealand for their excellent work on this clinical trial and their ongoing elucidation of the role of urocortins in heart failure."
Clinical chemistry, hematology and urinalysis values were assessed and no statistically significant differences were reported between the subjects who received urocortin 2 or placebo, with the exception of an increase in plasma creatinine concentration during the 4-hour infusion period.
Adverse event reporting indicates that 55% of subjects randomized to urocortin 2 reported transient flushing (vs. 23% in the placebo group). Four subjects had lowering of systolic blood pressure below pre-set "stop" values which, although asymptomatic, per protocol required a decrease or cessation of urocortin 2 infusion.
"This study provides additional insights in the potential utility of urocortin 2 in the management of heart failure," said Dr. Mark Richards, Director of The Christchurch Heart Institute. "We look forward to presenting the detailed clinical and laboratory data at an upcoming scientific meeting later this year."
Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences commented, "We are pleased with the results of this study and will continue to rely on outside parties to further investigate urocortin 2 in clinical settings, while we remain focused on our neurological and endocrine based pipeline."
Neurocrine Biosciences, Inc.