Neurocrine: Phase 2a results show urocortin 2 increases cardiac ejection fraction in heart failure patients

By E. Janene Geiss

Philadelphia, Dec. 19 - Neurocrine Biosciences, Inc. said Monday that results from its phase 2a clinical trial with two dose levels of urocortin 2 in patients with mild to moderate congestive heart failure demonstrated a dose-related increase in cardiac output of up to 40% with only a modest increase (6%) in heart rate.

In addition, seven out of eight patients exhibited improvement in cardiac ejection fraction. Patients also exhibited mild to moderate reductions in both diastolic and systolic blood pressure without adverse effect, according to a company news release.

Preliminary analysis showed a correlation between pharmacokinetic and pharmacodynamic parameters and the drug was safe and well tolerated with no serious adverse events reported, officials said.

The phase 2a 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 eight 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.

"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 [congestive heart failure], we will further optimize the dose and infusion duration in [those] patients in an extension of this study in the first half of 2006," Wendell Wierenga, executive vice president of research and development, said in the release.

Neurocrine said it filed an Investigational New Drug Application with the Food and Drug Administration to initiate the extension study and evaluate dose/duration in acute decompensated heart failure patients.

Urocortin 2 has a novel mechanism of action, and based on the company's preclinical and clinical efficacy and safety data, together with its known role in human physiology, Neuroscience said it believes urocortin 2 has positive hemodynamic effects on cardiac output and blood pressure that will bring important new benefits to patients with acute decompensated heart failure.

Neurocrine Biosciences, Inc. is a San Diego product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

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