GSK has advanced a novel lead CRF1 receptor antagonist compound, 561679, into a Phase II trial in patients with major depressive disorder. Enrollment of approximately 150 subjects is anticipated in this 6-week randomized, double-blind, placebo-controlled trial.
In addition to the two compounds listed above, GSK has also successfully completed a Phase I single dose-escalating clinical trial with a third CRF1 compound, 586529, for the treatment of anxiety and depression.
Urocortin 2 for Congestive Heart Failure (CHF) Continues Preclinical Evaluation
Initiation of longer term (up to 72 hours in duration) Phase II clinical trials of urocortin 2 are awaiting additional preclinical data. The Company has identified five preclinical studies necessary to support the longer period of infusion in the clinical program. Two of these five preclinical studies were successfully completed by July 2008. The two completed studies were non- GLP toxicology and safety assessment studies over 14 days of continuous infusion in distinct species models. The favorable results of these studies now await confirmation in the GLP preclinical studies anticipated later in 2008.
The Company met with the FDA in July for an end of review meeting related to the December 12, 2007 approvable letter for indiplon capsules. The FDA meeting focused on the three additional requirements outlined in the approvable letter. After exchange of correspondence regarding meeting minutes, the Company is awaiting the FDA's final version of these minutes to determine the next course of action related to indiplon capsules.
Conference Call and Webcast Today at 5:00 p.m. Eastern Daylight Time
Neurocrine will hold a live conference call and webcast tod
|SOURCE Neurocrine Biosciences, Inc.|
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