Organon announced the discontinuation of its investigational endometriosis drug OG-6219 after the compound failed to demonstrate efficacy in a Phase II clinical trial. The oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor did not meet its primary endpoint of improving moderate-to-severe endometriosis-related overall pelvic pain compared to placebo in the ELENA proof-of-concept study.
Trial Design and Results
The randomized, double-blind, placebo-controlled, parallel-group, global multi-center Phase 2a/b study (NCT05560646) evaluated three dose levels of OG-6219 in pre-menopausal women aged 18 to 49 years who had been surgically diagnosed with endometriosis. Eligible patients were randomized to receive one of three doses of OG-6219 or placebo orally twice daily.
The primary efficacy endpoint measured the change from baseline to the third month of treatment in mean endometriosis-related overall pelvic pain score using an eleven-point numerical rating scale. The study failed to show statistically significant improvement in pain relief compared to placebo.
Strategic Impact and Company Response
"While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis," said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon.
The company acquired OG-6219 through its 2021 acquisition of Forendo Pharma, a Finnish company focused on sex steroid physiology in women. Organon paid up to $954 million for the deal, with most of the value tied to various developmental and regulatory milestones. The acquisition was part of Organon's strategy to build a pipeline of new assets following its 2020 spinout from Merck.
Endometriosis Treatment Landscape
Endometriosis is characterized by the growth of uterine tissues outside of the uterus, causing infertility, excessive menstrual cramps, heavy menstrual bleeding, and pain during intercourse. Current treatment options include laparoscopic surgery for diagnosis and treatment, while non-surgical approaches focus on pain management or hormone therapy.
Despite this setback, Organon pledged continued support for pursuing new treatment options for women with endometriosis. The company maintains a portfolio of over 70 products across Women's Health and General Medicines, including biosimilars, with operations in over 140 markets worldwide.
