US-based AbbVie and Neurocrine Biosciences have started the first of two Phase III trials to evaluate Elagolix in patients with uterine fibroids.
Elagolix is an orally administered, gonadotropin-releasing hormone (GnRH) antagonist. It is currently being evaluated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.
The two clinical trials are part of the company’s Elagolix Phase III uterine fibroid clinical development programme.
They will evaluate the change in menstrual blood loss using the alkaline hematin method, comparing baseline to results after six months of treatment.
Additional secondary endpoints will include changes in fibroid volume, monthly blood loss and hemoglobin levels, as well as bone mineral density.
Around 400 subjects will be enroled in each trial for an initial six-month, placebo-controlled dosing period. Following this, eligible subjects will have an option to continue for an additional six-month dosing period in a safety and efficacy extension study.
Upon enroling its first patient, AbbVie will make a $15m milestone payment to Neurocrine Biosciences.
AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: "There are limited, non-surgical treatment options for women suffering from heavy menstrual bleeding associated with uterine fibroids. AbbVie is eager to further explore Elagolix’s potential to address this unmet need."
Uterine fibroids are noncancerous muscle tissue tumours found in the uterus. They are most common in women aged 30 to 40 years, but can occur at any age.
Fibroids can reportedly range in size from nearly undetectable to bulky masses that can distort the uterus.
Elagolix has so far been evaluated in more than 40 clinical trials and more than 3,000 subjects.