Neurocrine Biosciences, Inc.
NBIX today announced that a Phase IIb clinical trial to evaluate
elagolix for the treatment of uterine fibroids has been initiated. Elagolix is
an oral gonadotropin-releasing hormone (GnRH) antagonist, in development by
AbbVie for the treatment of uterine fibroids and endometriosis. Neurocrine and
AbbVie entered into a collaboration and license agreement for elagolix during
2010.
"Based on the positive data from the uterine fibroids Phase IIa trial, AbbVie
has progressed elagolix into Phase IIb for uterine fibroids," said Kevin C.
Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We
are pleased with this advancement, as well as the ongoing Phase III program in
endometriosis, and look forward to the continued development of elagolix in
these two disease states which both have high unmet medical needs."
The Phase IIb uterine fibroids study is a randomized, parallel, double-blind,
placebo-controlled clinical trial evaluating elagolix in women with heavy
uterine bleeding associated with uterine fibroids. This study will evaluate
280 subjects over a six-month placebo-controlled dosing period. The primary
efficacy endpoint of the study is an assessment of the change in menstrual
blood loss utilizing the alkaline hematin method comparing baseline to month
six. Additional secondary efficacy endpoints will be evaluated including
assessing the change in fibroid volume and hemoglobin. Bone mineral density
will be assessed via DXA scan at baseline, the conclusion of dosing, and six
months post-dosing.
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