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news.Elagolix provides with clinical improvement of symptoms and tolerability profile to endometriosis sufferers
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Neurocrine Biosciences, a product based biopharmaceutical company, has announced top-line efficacy and safety results from its fourth Phase II clinical trial using its orally-active nonpeptide gonadotropin-releasing hormone receptor antagonist, elagolix, in patients with endometriosis.
The 702 study (Lilac Petal study) randomized 155 patients with a confirmed diagnosis of endometriosis into three treatment arms; elagolix 150mg once daily, elagolix 250mg once daily, or placebo. After completion of the initial three months of treatment, placebo recipients were re-randomized to elagolix for an additional three months. The top-line results reflect the three-month placebo-controlled portion of the study.
The Lilac Petal study assessed endometriosis pain through a variety of measures, several of which were never before utilized in an endometriosis trial. These exploratory endpoints included three daily assessments using an electronic diary: a numeric rating scale (NRS) for pain (scale 0-10); a dysmenorrhea pain assessment (scale 0-3); and a non-menstrual pelvic pain assessment (scale 0-3).
The trial also utilized two validated efficacy endpoints consisting of the patient global impression of change, an assessment of the changes in endometriosis-related pain; and the endometriosis health profile 5 (EHP-5), a disease specific quality of life scale.
The top-line data confirm that elagolix provides endometriosis sufferers with clinical improvement of symptoms, coupled with an excellent safety and tolerability profile. However, certain aspects of the exploratory endpoints, used as an alternative to the validated composite pelvic signs and symptoms scale, require additional dialogue with the company’s expert advisors and regulatory authorities, said Neurocrine.
Kevin Gorman, president and CEO of Neurocrine Biosciences, said: This Phase II study provides the information we need to continue to move this program forward. While limitations were discovered in some of the new exploratory efficacy measures, elagolix again showed strong efficacy in the historical validated endometriosis measures, with an excellent safety profile.