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Yahoo
03-07-2025
- Health
- Yahoo
Organon discontinues endometriosis drug after Phase II flunk
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. 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.' Organon acquired the therapy as part of a $75m acquisition of Forendo Pharma in 2021. 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. "Organon discontinues endometriosis drug after Phase II flunk" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Reuters
02-07-2025
- Health
- Reuters
Organon abandons endometriosis pain drug development after trial failure
July 2 (Reuters) - Organon (OGN.N), opens new tab said on Wednesday it will the stop development of an experimental treatment it acquired through its purchase of Forendo Pharma, after the drug failed to reduce pelvic pain in women with endometriosis. The drug's failure in a proof-of-concept mid-stage study deals a blow to the company's attempt to launch a future driver of revenue, four years after it was spun off from Merck (MRK.N), opens new tab. Another drug acquired by Organon through the up to $954 million Forendo acquisition is still in lab studies. Organon was testing the drug, OG-6219, in 354 patients aged 18 to 49 who had moderate-to-severe endometriosis-related pain, but results showed no significant improvement compared to a placebo. Improvement in pelvic pain was measured using an 11-point rating scale during the third month of treatment. Endometriosis is a condition that affects about 190 million women of reproductive age globally, according to the World Health Organization. It occurs when tissue similar to the uterine lining grows outside the uterus, often causing chronic pelvic pain and infertility. Organon's study was designed to assess whether the drug could meaningfully reduce pelvic pain and patients were randomly chosen to receive one of three pre-decided doses of the drug or a placebo, given orally twice a day. Current treatments options for endometriosis include hormonal therapies such as birth control pills, progestins, and GnRH modulators such as Myfembree, co-owned by Sumitovant Biopharma and Pfizer (PFE.N), opens new tab, and AbbVie's (ABBV.N), opens new tab Orilissa. Pain is often managed with non-steroidal and anti-inflammatory medicines such as ibuprofen and surgery remains an option for severe cases. OG-6219 is designed to block an enzyme involved in estrogen production, aiming to reduce pain by lowering levels of estradiol at endometriosis sites without affecting hormone levels throughout the body.
