TiumBio announces positive data from trial of Merigolix in patients with endometriosis

The biopharmaceutical company TiumBio has announced positive results from its clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor drug, in patients with moderate to severe endometriosis-associated pain.

The trial, according to TiumBio, achieved its primary endpoint of reducing dysmenorrhea scores compared to placebo across all three dose groups, demonstrating a statistically significant difference.

The study enrolled 86 female patients with moderate to severe endometriosis-associated pain across five European countries to evaluate the efficacy and safety of Merigolix in endometriosis.

The patients were randomised to receive either Merigolix 120 mg, Merigolix 240 mg, Merigolix 320 mg, or a placebo once daily for 12 weeks.

The change in endometriosis-associated pain from baseline to 12 weeks of treatment was assessed by measuring the mean dysmenorrhea score using the numeric rating scale (NRS) over the past month.

TiumBio said Merigolix achieved statistically significant and clinically meaningful improvements in mean dysmenorrhea scores from baseline compared to the placebo group at all tested doses.

The treatment was generally well tolerated, the company said, with no serious treatment-related adverse events, consistent with prior studies.

The most commonly reported adverse events in the study population were hot flush, headache and nausea.

“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,” said Hun-Taek Kim, founder and CEO of TiumBio.

“This clinical trial confirmed that Merigolix achieved superior clinical outcomes in reducing dysmenorrhea and ensuring safety compared to other GnRH antagonists.”

He added: “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.”