TiumBio, a clinical-stage biopharmaceutical company based in South Korea, recently unveiled encouraging findings from its Phase 2a clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, aimed at alleviating moderate to severe endometriosis-associated pain. This announcement comes on the heels of a successful $12 million funding round, earmarked to advance the company’s clinical pipeline.
The Phase 2a trial showcased promising results, meeting its primary endpoint of reducing dysmenorrhea (menstrual pain) scores across all tested doses (120 mg, 240 mg, and 320 mg) compared to a placebo. Notably, Merigolix demonstrated statistically significant improvements in dysmenorrhea scores at all dosage levels, indicating a marked reduction in endometriosis-associated pain.
The study enrolled 86 female participants with moderate to severe endometriosis-associated pain across five European countries. Patients were randomized to receive Merigolix at varying doses or a placebo once daily for a duration of 12 weeks. Results indicated a noteworthy decrease in dysmenorrhea scores from baseline across all Merigolix dosage groups, underscoring its potential as an effective treatment option for endometriosis-related pain management.
“Despite the small size of each group, with around 20 patients per group, Merigolix showed statistically significant efficacy compared to placebo at all doses in the Phase 2a clinical trial. This clinical trial confirmed that Merigolix achieved superior clinical outcomes in reducing dysmenorrhea and ensuring safety compared to other GnRH antagonists,” said Hun-Taek Kim, Ph.D., MBA, CEO, TiumBio. “Now that this proof of concept study has supported potential for Merigolix, we aim to develop Merigolix into a best-in-class treatment for patients with endometriosis,” he added.
