Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has recently announced the positive safety and efficacy results with completion of the second off-treatment 3-month period of its 6-month 'proof of concept', safety, efficacy and dose-finding Phase II clinical trial using NBI-56418.
NBI-56418 is Neurocrine Biosciences’ proprietary, orally-active small molecule Gonadotropin-Releasing Hormone (GnRH) receptor antagonist in endometriosis.
According to Chris O'Brien, M.D., Senior Vice President of Clinical Development for Neurocrine Biosciences:
"Now that the trial is complete, the data show that this oral GnRH antagonist reduces pain scores using several different standardized measures.
More importantly, this first study in patients with endometriosis reveals that pain reduction may be achieved without profound suppression of estradiol or suppression of menses.
If these findings are confirmed in subsequent clinical trials, women with endometriosis may one day be able to achieve pain control without suppression of menses and without high risk of bone loss.”
NBI-56418 was generally well tolerated and adverse event rates show that there is little difference in the frequency of treatment emergent adverse events across treatment groups.
Read more details from the press release.
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