Merigolix (TU2670), an investigational once-daily oral gonadotropin-releasing hormone (GnRH) receptor antagonist developed by TiumBio, has demonstrated significant clinical progress across multiple women's health indications, according to recent announcements from the South Korean biopharmaceutical company.
In a Phase 2 clinical trial for uterine fibroids conducted by TiumBio's Korean partner Daewon Pharmaceutical, merigolix successfully met its primary endpoint, showing statistically significant reduction in heavy menstrual bleeding across all dosage groups compared to placebo. The trial enrolled 71 women who received high, medium, or low doses of merigolix or placebo once daily for 12 weeks, followed by a 12-week observation period.
Beyond the primary endpoint, the drug demonstrated meaningful improvements in several secondary measures, including fibroid size reduction, increased hemoglobin levels, and relief of pelvic pain. The safety and tolerability profile remained consistent with previous clinical data, with no new safety signals identified.
"We are very excited that merigolix has demonstrated excellent therapeutic efficacy not only in endometriosis but also in uterine fibroids," said Hun-Taek Kim, Ph.D., MBA, CEO of TiumBio. "Successfully achieving both efficacy and safety in Phase 2 significantly increases the probability of regulatory approval and licensing opportunities."
Expansion into Assisted Reproductive Technology
In a parallel development, TiumBio's Chinese partner Hansoh Pharma recently received approval for an Investigational New Drug (IND) application to study merigolix in Assisted Reproductive Technology (ART), specifically for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation (COS).
This expansion represents a strategic advancement for the compound, as ART treatments typically require shorter treatment periods than other indications, potentially enabling faster clinical development. The oral administration route could offer significant advantages over current injectable GnRH products used in COS regimens, potentially reducing patient discomfort and treatment costs.
"Hansoh Pharma's selection of ART as a new indication is significant," noted Dr. Kim. "Compared to other indications, ART requires a shorter treatment period, which will enable faster development."
Mechanism and Market Potential
Unlike traditional GnRH agonists that require injection and often cause an initial hormone surge, merigolix offers oral administration without the hormonal flare, providing faster onset of action and potentially improved treatment adherence.
Uterine fibroids affect approximately 20% of women over age 35, causing symptoms such as heavy menstrual bleeding, pelvic pain, and anemia. The condition represents a significant unmet medical need despite its high prevalence.
"Uterine fibroids are a condition that causes significant suffering for many women, and we believe merigolix has the potential to become an important new oral treatment that addresses this unmet medical need," said Jonathan In Baek, President of Daewon Pharmaceutical.
Partnership Strategy
TiumBio has established strategic partnerships to advance merigolix globally. In 2019, the company licensed Korean development and commercialization rights to Daewon Pharmaceutical. Separately, TiumBio entered into a licensing agreement with Hansoh Pharma worth up to $170 million plus tiered royalties, granting exclusive rights to develop and commercialize merigolix in Greater China.
The multi-indication development strategy—with clinical trials underway for uterine fibroids, endometriosis, and ART—enhances the asset's value and positions merigolix as a potential best-in-class candidate in women's health.
About TiumBio
TiumBio (KOSDAQ: 321550) is a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases. Beyond merigolix, the company's pipeline includes TU2218, a first-in-class oral immuno-oncology therapy targeting TGF-β and VEGF pathways, and TU7710, a novel recombinant Factor VIIa designed with extended half-life for hemophilia patients with inhibitors.
