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 placebo on 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.
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