Shares of drug developer, Neurocrine Biosciences, Inc. (Nasdaq: NBIX) were up 54 percent in morning trading on Tuesday, after the company announced “statistically significant and clinically meaningful” top-line efficacy results from its Daisy PETAL phase II study of elagolix, a treatment for patients with endometriosis.
The San Diego-based company said the drug, elagolix, showed statistically significant reductions in pelvic pain during menstruation, and non-menstrual pelvic pain and dyspareunia, or painful intercourse, when compared to placebo. The US based Daisy PETAL study enrolled 137 endometriosis subjects into one of two treatment groups; elagolix 150 mg or placebo once daily for two months of treatment, in a double-blind design. Subjects are continuing for four months of open-label elagolix treatment and assessments. These top-line efficacy results are based on the ITT population of 132 women.
Shares began rallying in after-hours trading on Monday, after the company issued its announcement.
“The Daisy PETAL study was successful, all primary and secondary efficacy endpoints were met, and provided exactly the information we need to move this program forward,” said Chris O’Brien, M.D., Chief Medical Officer at Neurocrine in a statement. “We now have confirmation that the daily scales for menstrual and non-menstrual pelvic pain, developed with extensive input from the FDA and patients, function well in a clinical trial setting. These daily endpoints reflect the way women with endometriosis experience their symptoms and also demonstrate improvement with elagolix.”
Shares of NBIX have been up as much as 58 percent in the past three months.