TiumBio and Daewon Pharmaceutical Successfully Complete Phase 2 Clinical Trial of 'Merigolix (TU2670
Primary Endpoint Met: Statistically significant reduction in heavy menstrual bleeding achieved in all dosage of Merigolix groups compared to placebo
Broader Therapeutic Potential: Positive Phase 2 results in both uterine fibroids and endometriosis could place Merigolix as a strong best-in-class candidate for novel drug approval and global licensing opportunities
Multi-Indication Development: Clinical trials are underway for three indications enhancing the asset value-uterine fibroids, endometriosis, and assisted reproductive technology (ART), the latter in collaboration with Hansoh Pharma in China
SEONGNAM, South Korea, May 7, 2025 /PRNewswire/ -- TiumBio (KRX: 321550.KQ), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable disease, today announced that Merigolix (code name: TU2670, Daewon's code name: DW4902) has successfully met the primary endpoint of reducing heavy menstrual bleeding in a Phase 2 clinical trial for uterine fibroids. In this trial, Merigolix demonstrated statistically significant improvements across all dosage groups compared to placebo in patients with uterine fibroids.
Merigolix is an investigational, once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist. Unlike traditional GnRH agonists, which require injection and often lead to an initial hormone surge, Merigolix offers a more patient-friendly oral administration without an initial hormonal flare, providing a faster onset of action and improved treatment adherence.
The Phase 2 clinical trial of Merigolix in uterine fibroids was conducted by TiumBio's partner, Daewon Pharmaceutical, and enrolled a total of 71 women diagnosed with uterine fibroids. Participants were randomly assigned to receive high, medium, or low doses of Merigolix, or placebo, administered orally once daily for 12 weeks, followed by a 12-week observation period. The results showed that Merigolix led to statistically significant improvements in heavy menstrual bleeding (HMB)—a validated clinical endpoint—across all dosage groups compared to the placebo.
In addition to the primary endpoint, Merigolix demonstrated statistically and clinically meaningful improvements in several key secondary endpoints, including fibroid size reduction, increased hemoglobin levels (indicating improved anemia), and relief of pelvic pain. The safety and tolerability profile of Merigolix was consistent with prior clinical data, with no new safety signs.
The mechanism of action of Merigolix can be used in various disorders, including endometriosis, uterine fibroids, ART, precocious puberty, and prostate cancer. Notably, in a separate Phase 2 clinical trial for endometriosis completed in 2024, Merigolix also showed excellent therapeutic efficacy and safety, further reinforcing its potential as a promising new treatment.
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