The Company is also currently conducting two additional randomized placebo-controlled Phase II clinical trials. The clinical endpoints for both of these trials are a reduction in pelvic pain associated with endometriosis, utilizing a scale proposed by the FDA. The first Phase II trial includes our selected commercial formulation tablet in two doses, (150 mg and 250 mg); this trial has completed randomization in 155 patients. The Company expects topline results from the first three months of treatment in the first quarter of 2009. The second trial is a four arm comparator trial of two doses of elagolix (150 mg and 250 mg), placebo or leuprolide depot. This trial is being conducted in Central and Eastern Europe. Topline data from this 3-month double-blind trial of approximately 180 patients should be available at the end of the first half of 2009.
Neurocrine is also investigating the potential of certain GnRH antagonists in treating other hormone-dependent diseases in Men's and Women's Health.
Corticotropin Releasing Factor (CRF1) Receptor Antagonists for Anxiety/Depression and IBS
The CRF collaboration between Neurocrine and GSK has identified
multiple unique high affinity and selective antagonists for the CRF1
receptor that are currently in clinical development for mood disorders and
irritable bowel syndrome (IBS). There are currently three distinct CRF
compounds in clinical development that have arisen out of the GSK
collaboration. The compound (876008) is in a Phase II "proof of concept"
trial to evaluate its safety and efficacy in patients with IBS.
Approximately 130 patients meeting established diagnostic criteria for IBS
have been entered into this cross-over design trial.
|SOURCE Neurocrine Biosciences, Inc.|
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