AbbVie, in cooperation with Neurocrine Biosciences, has announced that the Phase 3 ELARIS UF-I study (M12-815) of elagolix met its primary endpoint.
Results from the first of two pivotal Phase 3 studies demonstrated at month six that elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding with 68.5% (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7%), as measured by the alkaline hematin method.
Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.001) at month six.
Uterine fibroids are the most common type of abnormal growth in a woman’s pelvis and can affect up to 80% of women by age 50. Fibroids can be asymptomatic, but in approximately 25% of women, fibroids can cause symptoms, such as heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation, and anemia.
African American women are more likely to experience fibroids and do so at a younger age.
Hypoestrogenic effects, such as hot flush and reduction in bone mineral density, from elagolix treatment were observed in the study. In addition, the overall safety profile for elagolix was consistent with what was observed in Phase 2 studies in uterine fibroids.4-6 Data from the Phase 3 study will support regulatory submissions for elagolix and will be presented at an upcoming medical conference.
Dr Dawn Carlson, vice president, general medicine development, said: “The results from this study represent a significant advancement in the development of elagolix and demonstrate our continued commitment to address serious disease.”
Safety data, including most common adverse events, are currently being analysed. The topline results are from a six-month primary analysis. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.