SAN DIEGO, Dec. 19 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today positive safety and efficacy results from the Company’s Phase IIa clinical trial with two dose levels of urocortin 2 in patients with mild to moderate congestive heart failure (CHF). Results demonstrated a dose related increase in cardiac output of up to 40% with only a modest increase (6%) in heart rate. In addition 7 of 8 patients exhibited improvement in cardiac ejection fraction. Patients exhibited mild to moderate reductions in both diastolic and systolic blood pressure without adverse effect. Preliminary analysis showed a correlation between pharmacokinetic and pharmacodynamic parameters. The drug was safe and well tolerated. In addition, there were no serious adverse events reported.
“We are pleased with the results and look forward to advancing this novel compound through clinical development for the treatment of acute and chronic congestive heart failure. With this preliminary ‘proof of concept’ data in patients with stable CHF, we will further optimize the dose and infusion duration in CHF patients in an extension of this study in the first half of 2006,” said Dr. Wendell Wierenga, Executive Vice President of Research and Development for Neurocrine Biosciences. “Neurocrine filed an IND with the FDA to initiate the extension study and evaluate dose/duration in acute decompensated heart failure patients (ADHF). Urocortin 2 has a novel mechanism of action and based on our preclinical and clinical efficacy and safety data, together with its known role in human physiology, we believe urocortin 2 has positive hemodynamic effects on cardiac output and blood pressure that will bring important new benefits to patients with ADHF.”
Study Design
The Phase IIa trial was a single-blind, placebo-controlled, dose- escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dose levels of urocortin 2 in 8 patients with stable congestive heart failure. Patients were administered a one hour infusion of placebo or urocortin 2. Three doses were investigated in each patient over a four-week treatment period.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the Internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine’s business and finances and research programs in general including, but not limited to, risk and uncertainties associated with, or arising out of, drug discovery, pre-clinical and clinical development of products and specifically risk that urocortin 2 may prove unsuitable for continued clinical development; risk that our clinical trials will fail to demonstrate that urocortin 2 is safe and effective; risk relating to our reliance on contract manufacturers; risk that the Company could fail to meet its obligations under the urocortin 2 license which would cause it to forfeit product rights; uncertainties relating to patent protection for urocortin 2 and intellectual property rights of third parties in the urocortin field; impact of competitive products and technological changes that may limit demand for the Company’s products; risk that the Company will be unable to raise additional funding required to complete development of all of its product candidates; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2005 and most recent 10-Q filed for the third quarter ended, September 30, 2005. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
Source: Neurocrine Biosciences, Inc.
