ObsEva, a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced positive topline results from the Phase 3 EDELWEISS 3 trial of linzagolix in women with moderate-to-severe endometriosis-associated pain. The World Endometriosis Research Foundation estimates that endometriosis affects one in ten women during their reproductive years.
Endometriosis is a disease in which the endometrium (tissue lining the inside of the uterus) is found outside the uterus, where it induces a chronic inflammatory reaction that may result in scar tissue. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle.
In the Phase 3 EDELWEISS 3 Trial two doses were tested, a 200 mg once-daily dose of linzagolix in combination with add-back therapy (ABT) and a 75 mg dose of linzagolix without ABT. The 200 mg dose met the co-primary efficacy objectives, demonstrating reductions in dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) at 3 months. There were statistically significant and clinically meaningful improvements in the first five ranked secondary endpoints at 6 months: dysmenorrhea, non-menstrual pelvic pain, dyschezia, overall pelvic pain, and ability to do daily activities.
“While there have been recent advances in non-surgical endometriosis treatment, there is still a critical need for therapeutic options for women who suffer from this chronic condition,” said Hugh Taylor, MD, Professor and Chair of Obstetrics and Gynecology at Yale University. “Once daily linzagolix 200 mg with ABT demonstrated excellent efficacy along with minimal changes in bone mineral density, suggesting this dose may be used for long-term treatment. Availability of medical therapies that can be used long-term is important for this typically younger patient population.. The demonstration of improvement in dyschezia is of particular interest as this is the first Phase 3 trial of an oral GnRH antagonist to report efficacy in this common and debilitating symptom of endometriosis.”
Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix has completed clinical trial development for the treatment of heavy menstrual bleeding associated with uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.
(Press release / SK)
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