TiumBio and Daewon Complete Phase 2 Trial of Merigolix for Uterine Fibroids

TiumBio, a biopharmaceutical company based in South Korea, has announced promising results from a Phase 2 clinical trial of Merigolix, an investigational oral medication for the treatment of uterine fibroids. Merigolix, also known by its code names TU2670 and DW4902, achieved the primary endpoint of significantly reducing heavy menstrual bleeding in all dosage groups when compared to a placebo.

Uterine fibroids are non-cancerous growths in the uterus that affect many women of reproductive age, particularly those in their 30s and older. These fibroids can lead to symptoms such as heavy menstrual bleeding, pelvic pain, and anemia. The prevalence of uterine fibroids is approximately 20% among women over the age of 35, highlighting the need for effective treatments.

Merigolix is a once-daily oral gonadotropin-releasing hormone (GnRH) receptor antagonist. Unlike traditional GnRH agonists, which require injections and can cause an initial hormone surge, Merigolix offers a more convenient oral administration with a faster onset of action and improved treatment adherence due to the absence of initial hormonal flare-ups.

The Phase 2 trial, conducted in partnership with Daewon Pharmaceutical, involved 71 women with uterine fibroids. Participants were assigned to receive high, medium, or low doses of Merigolix, or a placebo, for 12 weeks, followed by a 12-week observation period. The study found that Merigolix led to statistically significant reductions in heavy menstrual bleeding across all dosage groups compared to placebo.

In addition to its primary endpoint, Merigolix showed positive outcomes in secondary measures, including a reduction in fibroid size, increased hemoglobin levels indicating improved anemia, and relief from pelvic pain. The safety profile of Merigolix was consistent with previous data, with no new safety concerns identified.

Merigolix's mechanism of action allows it to be considered for treating a range of conditions, including endometriosis, uterine fibroids, assisted reproductive technology, precocious puberty, and prostate cancer. Notably, a separate Phase 2 trial for endometriosis completed in 2024 also demonstrated Merigolix's therapeutic efficacy and safety, strengthening its potential as a robust new treatment option.

Hun-Taek Kim, Ph.D., MBA, CEO of TiumBio, expressed enthusiasm over the results, noting that achieving both efficacy and safety in Phase 2 trials boosts the likelihood of regulatory approval and licensing opportunities. TiumBio plans to expedite development and expand into the global market for uterine fibroid treatments.

Jonathan In Baek, President of Daewon Pharmaceutical, also commented on the results, emphasizing Merigolix's potential to address a significant medical need and provide an effective new oral treatment for women suffering from uterine fibroids.

In 2019, TiumBio entered a licensing agreement with Daewon Pharmaceutical, granting Daewon the rights to develop and commercialize Merigolix in South Korea.

TiumBio is a clinical-stage biopharmaceutical firm dedicated to developing novel therapies for rare and incurable diseases. Alongside Merigolix, TiumBio is advancing other promising drugs, including TU2218, an oral immune-oncology therapy, and TU7710, a novel treatment for hemophilia patients with inhibitors. The company's mission is to alleviate the burden of debilitating diseases through innovative drug discovery and development.