AbbVie and Neurocrine Biosciences have reported positive results from a Phase IIb clinical trial of elagolix to minimise menstrual bleeding in women with uterine fibroids.
Elagolix is an orally administered, short-acting molecule being developed to block endogenous gonadotropin-releasing hormone (GnRH) signalling.
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The trial results showed that 300mg elagolix met the primary efficacy endpoint by decreasing heavy menstrual bleeding.
The 24-week, multi-centre, double-blind, randomised, placebo-controlled, parallel group Phase II M12-813 trial assessed the efficacy and safety of elagolix alone or in combination with estradiol / norethindrone acetate add-back therapy compared to placebo.
The trial was performed in 567 pre-menopausal women aged 18-51 at 100 sites in the US, Canada, Puerto Rico, Chile and the UK.
AbbVie chief medical officer and development vice-president Rob Scott said: "Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options.
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By GlobalData"The positive results from this clinical trial represent a significant milestone in the development of elagolix, support AbbVie's ongoing Phase III uterine fibroids research and demonstrate our continued commitment to address complex and serious diseases."
The primary endpoint of the trial is to measure the change in menstrual blood loss at month six using the alkaline hematin method.
A significant decrease in the number of heavy bleeding days and increase in the haemoglobin concentration were observed at month six.
It was found that elagolix was well-tolerated, minimised symptom severity and improved quality of life.
The firm's Phase III uterine fibroids programme includes study of elagolix under two replicate, six-month efficacy and safety trials and a six-month safety and efficacy extension study.
