SAN DIEGO, Sept. 14 /PRNewswire-FirstCall/ — 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.
Neurocrine Biosciences, Inc. is a biopharmaceutical company
focused on neurological and endocrine diseases and disorders. Our
product candidates address some of the lar
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