Organon is terminating development of its endometriosis drug after the Phase II trial failed to show any benefit.
The ELENA proof-of-concept study (NCT05560646) was evaluating Organon’s therapy, OG-6219, in endometriosis-related pain. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor.
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In the study, OG-6219 failed to demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo, the study’s primary endpoint.
As a result of the study, Organon said it will discontinue the OG-6219 clinical development program.
The randomised, double-blind, placebo-controlled study aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women aged 18 to 49 years who have been surgically diagnosed with endometriosis with moderate-to-severe endometriosis-related pain.
Organon’s research and development head Dr Juan Camilo Arjona Ferreira said: “While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier everyday for all women, including those living with endometriosis.”
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By GlobalDataOrganon acquired the therapy as part of a $75m acquisition of Forendo Pharma in 2021.
Endometriosis treatment remains limited
Current treatment options for endometriosis include pain relief medications, hormonal therapies or surgical options, which can include the removal of lesions or affected organs.
GlobalData predicts that the endometriosis market will grow from $938m in 2024 to $2.5bn in 2034 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). The increase is partially due to new pipeline therapies, increased awareness and improved diagnostic tools.
Some approved therapies used to treat endometriosis are Pfizer’s Myfembree (relugolix/estradiol/norethisterone acetate), Myovant and Gedeon Richter’s Ryeqo (relugolix/estradiol/norethisterone acetate) and Kissei Pharmaceutical and ObsEva’s Yselty (linzagolix).
While the pipeline is limited, GlobalData anticipates that three late-stage pipeline products will enter the endometriosis market by 2034: Kissei Pharmaceutical’s linzagolix, Hope Medicine’s HMI-115, and Fuji Pharma’s Alyssa (drospirenone and estetrol).
GlobalData is the parent company of Clinical Trials Arena.
