Organon Says Goodbye to Endometriosis Drug Candidate After Phase 2 Failure

An Organon medication candidate, regarded as its most significant prospective chance, has failed a phase 2 study, leading the firm to terminate clinical development of the endometriosis offering.

Organon, a women’s health firm, acquired the candidate OG-6219 via its acquisition of Forendo Pharma. In pursuit of establishing a research and development pipeline after its spin-off from Merck & Co., Organon disbursed $75 million upfront to buy the firm in 2021 and initiated a phase 2 trial the subsequent year.

OG-6219 is intended to specifically decrease local estrogen synthesis in tissue of the endometrium and endometriotic lesions while preserving systemic hormone concentrations. The process aimed to overcome the shortcomings of existing medicines that may lead to bone density reduction and menopausal symptoms, while possibly facilitating prolonged use.

Researchers randomly assigned 354 premenopausal women experiencing moderate to extreme pain due to endometriosis to one of three dosages of OG-6219 or a placebo. By blocking the synthesis of a hormone that controls the expansion of uterine tissue and may induce inflammation, Organon was hoping that OG-6219 would help with pain.

However, it was a losing gamble. The research failed to reach its main goal as Organon discovered that OG-6219 had no greater effect than placebo in lowering overall pelvic discomfort due to endometriosis. In response, the firm halted OG-6219’s clinical development.

The revelation weakens Organon’s efforts to introduce additional growth catalysts to bolster the authorized medications acquired from Merck. During an earnings call earlier this year, Juan Camilo Ferreira, director of research and development at Organon, described OG-6219 as maybe the most significant opportunity available to the company.

CEO Kevin Ali had described the medication as a “multibillion dollar opportunity” at the start of the year. The corporation had anticipated commencing Phase 3 studies in 2026 and introducing the medication by about 2029.

Organon could yet have a chance to make money off of the Forendo acquisition. During the February call, Ferreira noted that the firm had a contingency plans for OG-6219, which aligns with their objective of supplying a product using this innovative technique. Organon did not include the backup program in its announcement on the study’s failure and the cessation of OG-6219.

The outcome of the backup program notwithstanding, the collapse of OG-6219 will hinder Organon’s ambitions to provide a novel nonhormonal therapy for endometriosis. The business intends to initiate a phase 3 plan next year, aiming for product introduction by the decade’s conclusion.