ObsEva announced the completion of patient enrollment in a Phase 2b clinical trial to evaluate OBE2109, an oral gonadotropin releasing hormone (GnRH) receptor antagonist, for the treatment of endometriosis-associated pain.
The Phase 2b EDELWEISS clinical trial (NCT02778399) is expected to randomize 330 patients to study OBE2109’s safety and effectiveness by assessing multiple doses compared to a placebo.
The primary goal, or endpoint, is for patient response after 12 weeks of treatment to show at least 30% improvement in combined menstrual and non-menstrual pain, as measured by a four-point verbal rating scale (VRS). Results are anticipated by mid-2018.
The study also will set the foundation for a Phase 3 clinical program in endometriosis by helping validate the pain scoring system while identifying optimal doses that address different pain symptoms, so that full estrogen suppression and hormonal add back therapy (ABT) are unnecessary.
“The completion of patient recruitment in our Phase 2b EDELWEISS clinical trial is a testament to our clinical research and operations teams, and underscores ObsEva’s commitment to bringing new treatment alternatives to women suffering from debilitating diseases such as endometriosis,” Ernest Loumaye, MD, PhD, OB/GYN, ObsEva’s chief executive officer and co-founder, said in a press release.
OBE2109 is an orally administered GnRH receptor antagonist in late-stage clinical development for the treatment of pain linked to endometriosis and heavy menstrual bleeding associated with uterine fibroids.
The GnRH receptor antagonist acts by binding to and blocking the GnRH receptor in the pituitary gland, leading to reduced estrogen production by the ovaries.
Unlike other currently marketed GnRH agonists, OBE2109 has the potential to be administered orally once a day, with symptom relief within days. Additionally, OBE2109 has new properties that have the potential to allow for personalized dosing that can be tailored to a patient’s individual needs.
After licensing OBE2109 from Kissei in 2015, ObsEva now retains worldwide commercial rights, except in Asia. Kissei is the Japanese pharmaceutical company responsible for discovering OBE2109.
OBE2109 is also being studied in two Phase 3 clinical trials in subjects with heavy menstrual bleeding associated with uterine fibroids. These trials are PRIMROSE 1 (NCT03070899) and PRIMROSE 2 (NCT03070951).