Surgery and medical treatments are currently available for women with endometriosis (an approximate 6 million in the U.S.).
Surgery, however, is an option to many of these women and medical therapies (such as the injectable GnRH agonist leuprolide or injectable progesterone) are often associated with unacceptable side effects like bone loss and hot flashes.
Neurocrine Biosciences’ second 'proof of concept', safety and efficacy Phase II clinical trial over a 3-month treatment period using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist (NBI-56418) in patients with endometriosis, yielded preliminary positive results.
According to Chris O'Brien, M.D., Senior Vice President of Clinical Development and Chief Medical Officer for Neurocrine Biosciences:
"The results of the second exploratory Phase II study are consistent with the first study reported in 2006. Our GnRH antagonist demonstrated dose-related reductions of estradiol without evidence of increased risk of bone loss.
The reductions in pain scores were reported within days of treatment initiation for some women and patients with initial improvement continued to benefit throughout the treatment period.
The extent of estradiol suppression and lack of undesirable metabolic consequences suggest that even higher doses may be acceptable with the potential for greater symptom reduction.”
Find more details of the clinical data from the press release.
[Photo Credit: Chicago IVF]
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