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AbbVie announces positive results from Phase 2b trial of elagolix for women suffering from heavy menstrual bleeding associated with uterine fibroids; Plans to proceed to Phase 3 in women with uterine fibroids.

M2 EQUITYBITES-September 17, 2015-AbbVie announces positive results from Phase 2b trial of elagolix for women suffering from heavy menstrual bleeding associated with uterine fibroids; Plans to proceed to Phase 3 in women with uterine fibroids

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Biopharmaceutical company AbbVie (NYSE:ABBV) said on Wednesday that it has completed its Phase 2b clinical trial evaluating the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo in cooperation with Neurocrine Biosciences (NasdaqGS:NBIX).

The company added that the Phase 2b trial was conducted in women with heavy menstrual bleeding (HMB) associated with uterine fibroids, also called leiomyomas or myomas, are noncancerous muscle tissue tumors of the uterus and are most common in women aged 30-40 years but can occur at any age.

According to the company, elagolix is an oral agent currently being investigated for the inhibition of gonadatropin releasing hormone (GnRH) receptors in the pituitary gland which ultimately reduces circulating sex hormone levels. Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo.

This Phase 2b trial (M12-813) is a 24-week, randomized, double-blind, multicentre, placebo-controlled, two cohort-design study that evaluates the safety and efficacy of two different elagolix treatment regimens (300 mg BID and 600 mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate) was conducted at 100 sites in the US, Canada, Puerto Rico, Chile and the UK.

Following the successful Phase 2b trial, the Phase 3 programme is targeted to begin the first quarter of 2016 and will include two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study. The primary endpoint in Phase 3 studies will be the same as in the Phase 2b study: reduction in uterine blood flow as measured by the alkaline hematin method.

In conjunction, the final results from this 2b trial will be presented at a medical conference in the future. Elagolix Uterine Fibroid Phase 2a data have been accepted for presentation at the 2015 Annual Meeting of the American Society of Reproductive Medicine in Baltimore, October 2015.

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Date:Sep 17, 2015
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