Neurocrine Biosciences Announces Urocortin 2 Phase II Study Results in Patients With Acute Decompensated Heart Failure; Drug Generally Well Tolerated
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 (n=27) in contrast to placebo (n=26) where the mean arterial pressure was 92 +/- 3 mmHg at baseline and 89 +/- 4 mmHg at the end of the placebo infusion.
Heart rates were slightly higher during urocortin 2 infusion than placebo although these remained in normal range and comparable in both groups post infusion. In the subset of subjects undergoing right heart catheterization (n=20, 10 per arm), cardiac output increased markedly by over 50% in those randomized to urocortin 2 compared to unchanging values in the placebo group (p=0.003).
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