Neurocrine Announces Top-Line Results of Corticotropin Releasing Factor Antagonist GSK561679 for Treatment of Major Depressive Disorder
Study did not demonstrate a treatment effect compared to placebo.
SAN DIEGO, Sept 14, 2010 /PRNewswire via COMTEX/ --Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line efficacy and safety results from a Phase II clinical trial utilizing Corticotropin Releasing Factor (CRF1) receptor antagonist GSK561679 in patients currently experiencing a major depressive episode. This double-blind, placebo controlled trial randomized 150 patients into two treatment arms, 350 mg of GSK561679 daily and placebo, and was conducted in the United States by GlaxoSmithKline (GSK) under the GSK/Neurocrine CRF1 collaboration. The primary endpoint was change from baseline in the Bech Melancholia scale at Week 6 and a key secondary endpoint was change from baseline in the HAMD-17 scale at Week 6.
Results of statistical analysis using the intent-to-treat population revealed no benefit of GSK561679 compared with placeboon both the Bech Melancholia and HAMD-17 endpoints. The top-line results are based on the six week placebo-controlled portion of the study for the intent to treat population of 145 patients. From a safety perspective, there were no significant adverse events, and the drug was generally well tolerated.
"It is clear from this study that CRF1 remains a difficult drug target in the drive to improve current pharmaceutical therapies for depression," said Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We plan to meet with GSK in the coming months after the full clinical data set is complete to determine the next steps for the CRF depression program."
Three separate academic collaborative clinical trials are ongoing to evaluate the effects of GSK561679 in Post Traumatic Stress Disorder, anxiety and alcoholism.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, anxiety, depression, pain, diabetes, irritable bowel syndrome, insomnia, and other neurological and endocrine related diseases and disorders. 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 in general, as well as risks and uncertainties associated with the Company's CRF program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's CRF program include, but are not limited to, risk that GSK may terminate its development of GSK561679 and/or its collaboration with the Company; risk that the ongoing GSK561679 clinical trials will fail to demonstrate that GSK561679 is safe and effective; risk that the Company's CRF program backup product candidates will not prove suitable for clinical development; risk that the Company will be unable to raise additional funding required to complete development of its CRF program product candidates; risk associated with the Company's dependence on corporate partners for future clinical development, commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's CRF program products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2009 and reports on Form 10-Q for the quarter ended June 30, 2010. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
Posted: September 2010