Swiss-biopharma ObsEva will begin enrolling patients in its EDELWEISS Phase 2b clinical trial of OBE2109 to treat endometriosis, and the U.S. FDA has cleared the company’s investigational new drug (IND) application for the drug candidate.
“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 30 years and the currently available drugs have significant limitations,” ObsEva CEO Ernest Loumaye said in a press release.
“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,” he said.
The drug has been positively examined in more than 140 Japanese patients with endometriosis in studies conducted by Kissei Pharmaceutical. It resulted in a dose-dependent reduction in serum luteinizing hormone and estradiol within the optimal target range, which reduced pain related to endometriosis as well as use of analgesics and days of bleeding.
EDELWEISS is a Phase 2b randomized, double blind, dose-ranging and placebo-controlled clinical trial that will examine the safety and efficacy of OBE2109 in patients with pelvic pain associated with endometriosis. The trial will be conducted in about 50 clinical sites in North America and 15 sites in Europe.
Approximately 330 patients with a diagnosis of endometriosis will be enrolled and treated with OBE2109 for up to 24 weeks. The aim of the EDELWEISS clinical trial is to determine an optimal dosing regimen of the compound.
“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,” said Dr. Elke Bestel, MD, chief medical officer of ObsEva. Bestel said patient screening for the EDELWEISS study will begin in coming months.
OBE2109 is an orally active gonadotropin-releasing hormone (GnRH) antagonist that reduces estrogen production in the ovaries by preventing the endogenous gonadotropin releasing hormone (GnRH) from activating its pituitary receptors.