SAN DIEGO, June 16 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that data from Phase I and Phase II elagolix trials and preclinical work was presented at the 91st Annual Meeting of the Endocrine Society (ENDO 09) in Washington DC, June 10-13, 2009.
The first clinical abstract presentation at ENDO 09 reviews the results of a Phase I study in which elagolix was evaluated over six weeks (42 days) in 60 healthy premenopausal women. The study was a double-blind, placebo-controlled study in parallel groups in which 88% of the participants completed the treatment period. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and endocrine effects of elagolix. The results of this study showed that daily administration of elagolix induced partial suppression of gonadotropins for 12-18 hours per day with a return to baseline each morning for 42 days. The effect on gonadotropins translated in a dose related fashion to maintenance of low estradiol levels over the six week period without inducing severe hot flashes or excessive bone resorption as determined by n-telopeptide. Consistent pharmacokinetic profiles were maintained throughout the 42 days of treatment, and adverse events were comparable among the placebo and elagolix groups.
The second clinical abstract at ENDO 09 reports results from a Phase II study where the safety of elagolix was evaluated in 252 women with a confirmed diagnosis of endometriosis. The study was a randomized, double-blind study of elagolix and depo-subQ provera 104 (used as an active control) administered over six months followed by six months of additional assessments. The primary endpoint of the study was to assess the impact of elagolix on bone mineral density using dual energy x-ray absorptiometry (DXA) scanning at months six and twelve. The results showed that elagolix had no long-term bone risk during or after treatment.
'We are pleased to share this body of work with the scientific community,' said Chris O'Brien, Chief Medical Officer, Neurocrine Biosciences. 'An orally active gonadotropin releasing hormone antagonist with no long-term bone risk would be a significant step forward in the treatment of endometriosis and other hormone dependent diseases. These safety results support selection of the appropriate elagolix dose and regimen for the Phase III trials.'
Neurocrine Biosciences also presented a preclinical study which was designed to examine the impact of a gonadotropin releasing hormone (GnRH) antagonist on prostate tissue. The animal model provided detailed information on changes in prostate size, weight, hormone levels and cell immunohistochemistry.
