ObsEva, a Swiss biopharmaceutical company innovating women’s reproductive health and pregnancy therapeutics, announced that its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OBE2109 has been cleared and the company is authorized to begin enrolling patients in the Phase 2b clinical study (EDELWEISS) with OBE2109 for the treatment of endometriosis.
SOBE2109 is a novel, orally active, gonadotropin-releasing hormone (GnRH) antagonist with a potentially best-in-class profile that has been successfully tested in more than 140 Japanese patients with endometriosis. In those studies, conducted by Kissei Pharmaceutical Co., Ltd., treatment with OBE2109 demonstrated a dose-dependent reduction in serum luteinizing hormone and estradiol within the optimal target range, resulting in a reduction of endometriosis-related pain, analgesic use and bleeding days.
“Endometriosis is a painful, debilitating condition that affects more than 170 million women worldwide and is a leading cause of infertility. There has been little innovation in the field to treat this chronic condition over the last thirty years and the currently available drugs have significant limitations,” said Ernest Loumaye, CEO and Co-Founder of ObsEva. “The design of the EDELWEISS study supports the differentiated profile of OBE2109 as OBE2109‘s low PK/PD variability is particularly suitable to consistently maintain estradiol levels within an optimal range. We believe that OBE2109 has significant market potential and could emerge as the best-in-class GnRH antagonist, uniquely positioned to address a high unmet need in this women’s reproductive health condition.”
ObsEva’s EDELWEISS clinical trial is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to assess the efficacy and safety of OBE2109 in patients with endometriosis-associated pelvic pain. The study will be conducted in North America and Europe, with approximately 50 centers located in the US and 15 centers located in Europe. ObsEva expects to enroll approximately 330 endometriosis patients who will be treated daily for a period of up to 24 weeks.
“OBE2109 open IND enables us to proceed with our EDELWEISS study in endometriosis, which represents a major step forward in our clinical development strategy for OBE2109 and brings us one step closer to providing a therapeutic solution for women suffering from this condition,” stated Elke Bestel, M.D., Chief Medical Officer of ObsEva. Dr. Bestel added that patient screening for the EDELWEISS trial will begin in the coming months.
