Neurocrine Reports Results From Fourth Phase II Clinical Trial Of Elagolix

Neurocrine has reported six month safety and efficacy results from its fourth phase II clinical trial – orally-active, non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix – in patients with endometriosis.

The results showed consistency with previously reported six month (Petal Study) and three month (Lilac Petal Study) results and a favorable safety profile. It also showed that clinically meaningful efficacy has been confirmed through month six of the Lilac Petal Study, said the company.

Over the six month treatment period, elagolix 150mg once daily had minimal impact on bone mineral density (BMD). The 250mg once daily dose, as expected, had slightly greater percentage change from baseline at month six. The 150mg once daily BMD profile in this Lilac Petal Study is consistent with that previously demonstrated in the six-month Petal Study.

From an efficacy standpoint, the exploratory daily pain scales for Dysmenorrhea and Non-Menstrual Pelvic Pain demonstrated that women had minimal endometriosis pain symptoms at month six.

The overall assessment of benefit using the Patient Global Impression of Change (PGIC) revealed that 80% of elagolix 150mg subjects and 79% of elagolix 250mg subjects were ‘Much Improved’ or ‘Very Much Improved’. Subjects treated with elagolix also reported considerable improvement on the Endometriosis Health Profile (EHP-5), a validated endometriosis-specific scale which reveals the impact of treatment on a variety of health outcome domains.

Chris O’Brien, CMO of Neurocrine, said: We selected the 150 mg and 250 mg once daily doses for this study based upon predictions generated from extensive modeling of dose, estradiol and bone mineral density relationships. Prior to this study we anticipated that the 250 mg dose would provide exposure such that we would start to see an increased impact on bone mineral density in a small portion of study subjects. The Lilac Petal data confirm that our modeling of the dose-response curve was accurate. Most importantly, we find that the 250 mg once-daily dose, chosen to inform us about the upper limit of dosing, met the pre-defined threshold for bone impact.