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Neurocrine Biosciences Reports Fourth Quarter and Year-End 2007 Results
Date:2/5/2008

agonists for the CRF1 receptor that are currently in clinical development for mood disorders and IBS. GSK has completed the first Phase II "proof of concept" clinical trial with a lead CRF1 receptor antagonist compound, 876008, for SocAD and has completed recruiting for a Phase II "proof of concept" clinical trial in IBS.

In the first double-blind, randomized, placebo controlled, multiple dose study to evaluate the safety and efficacy of the CRF1 receptor antagonist compound in patients with SocAD no statistically significant differences were observed in the key efficacy endpoints between 876008 and placebo at 12 weeks. This study included more than 200 adult subjects and assessed efficacy, safety, tolerability and pharmacokinetics of the compound and the drug was generally well tolerated with no serious adverse events reported.

The second "proof of concept" trial is a Phase II double-blind, randomized, placebo controlled study to evaluate the safety and efficacy of 876008 in patients with IBS. Approximately 130 patients meeting established diagnostic criteria for IBS have been entered into this cross-over design trial. Standard assessments of safety, tolerability and pharmacokinetics will be conducted. The clinical endpoints reflect change in symptom frequency and severity via validated scales for IBS and the data should be available in the second half of 2008.

GSK is advancing the second lead CRF1 receptor antagonist, 561679, into a Phase II depression study later this year. GSK has also initiated a Phase I single dose escalating clinical trial with 586529, an additional CRF1 receptor antagonist compound.

Additional Programs:

Urocortin 2 for congestive heart failure (CHF):

-- Initiation of longer term (up to 72 hours in duration) Phase II

clinical trials of urocortin 2 are awaiting additional preclinical

data. We have identified a preclinical formulation that allows for the

necessary precl
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SOURCE Neurocrine Biosciences, Inc.
Copyright©2008 PR Newswire.
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