NEUROCRINE, GSK LAUNCH TRIALS OF CRF1 ANTAGONIST

Neurocrine Biosciences announced that under a collaboration with GlaxoSmithKline (GSK), GSK has initiated Phase II proof of concept clinical trials with a lead Corticotropin Releasing Factor R1 (CRF1) receptor antagonist compound for two indications: social anxiety disorder and irritable bowel syndrome (IBS). As a result, Neurocrine has recognized an $8 million milestone payment from GSK.

The is a Phase II double-blind, randomized, placebo-controlled, multiple-dose study to evaluate the safety and efficacy of the CRF1 antagonist compound in patients with social anxiety disorder. The four-arm study will include more than 200 adult subjects with generalized social anxiety disorder. Efficacy, safety, tolerability and pharmacokinetics will be assessed. The clinical endpoints of the study include validated scales for assessment of anxiety disorders including the Leeds Situational Anxiety Scale and the Social Avoidance and Distress Scale and the Sheehan Disability Scale.

The second is a Phase II double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of this compound in patients with IBS. Approximately 100 patients meeting established diagnostic criteria for IBS will be 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.

Neurocrine and GSK entered into a worldwide research, development and commercialization agreement in J2001 for CRF1 receptor antagonists to treat psychiatric, neurological and gastrointestinal diseases.