Organon (NYSE: OGN), a global healthcare company focused on women’s health, has announced that its Phase 2 ELENA proof-of-concept study evaluating OG-6219 for endometriosis-related pain did not meet its primary efficacy endpoint. As a result, the company will discontinue the clinical development of OG-6219.
OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, initially acquired by Organon through its 2021 acquisition of Forendo Pharma. In the randomized, double-blind, placebo-controlled, global multi-center Phase 2a/b trial (NCT05560646), OG-6219 failed to show improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo.
“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. “We are grateful to all the patients, caregivers, and investigators for their participation in and support of this study.”
The trial evaluated three dose levels of OG-6219 in pre-menopausal women aged 18 to 49, all of whom had been surgically diagnosed with endometriosis. Participants were randomly assigned to receive either OG-6219 or a placebo orally twice a day. The study’s primary endpoint measured the change in overall pelvic pain score, using an 11-point numerical rating scale, from the baseline cycle to the third month of treatment exposure.
The company emphasized that despite the setback, it will continue advancing its broader women’s health mission, including addressing conditions like endometriosis that significantly impact quality of life.
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.
