TiumBio Reports Positive Phase 2a Results for Merigolix in Endometriosis Pain

TiumBio Co., Ltd., a clinical-stage biopharmaceutical company based in Boston and Seongnam, South Korea, announced promising results from its Phase 2a clinical trial of Merigolix. Merigolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist being studied for its effectiveness in reducing pain associated with moderate to severe endometriosis.

The study, identified as NCT05138562, successfully achieved its primary endpoint, which was the reduction of menstrual pain scores from baseline to 12 weeks compared to a placebo. The trial tested three different doses of Merigolix: 120 mg, 240 mg, and 320 mg. All dosage groups showed significant improvement in menstrual pain scores.

Eighty-six female patients from five European countries participated in the trial. They were randomized to receive either Merigolix at one of the three dosages or a placebo once daily for 12 weeks. The efficacy of Merigolix was measured through changes in dysmenorrhea scores from baseline to the end of the 12-week period. Results were quantified using the Numeric Rating Scale (NRS) for pain over the past month.

Merigolix demonstrated statistically significant and clinically meaningful improvements in dysmenorrhea scores across all doses compared to the placebo group. Specifically, the reductions in pain scores were -4.3 points at 120 mg (p=0.044), -5.4 points at 240 mg (p=0.001), and -6.2 points at 320 mg (p<0.001), compared to a -2.7 point reduction in the placebo group.

The treatment was generally well tolerated with no serious treatment-related adverse events. The most common side effects included hot flushes, headaches, and nausea, aligning with previous studies.

Dr. Hun-Taek Kim, CEO of TiumBio, emphasized the significance of these findings, stating that Merigolix demonstrated superior clinical outcomes in reducing dysmenorrhea compared to other GnRH antagonists. He expressed optimism about Merigolix becoming a best-in-class treatment for endometriosis. The company also sees potential applications for Merigolix in other conditions like uterine fibroids, with ongoing clinical trials in China and the Republic of Korea expected to yield positive results.

Merigolix is particularly noteworthy for its oral administration and favorable safety profile, distinguishing it from traditional GnRH agonists. It is expected to offer improved convenience and safety for patients.

Endometriosis, which affects up to 30% of women of childbearing age, involves the growth of endometrial tissue outside the uterus, leading to severe pelvic pain, menstrual pain, and possibly infertility. The condition affects approximately 200 million women worldwide.

The endometriosis market is projected to reach around $2.7 billion by 2030 in seven major countries: the US, Germany, France, Italy, the UK, Spain, and Japan. GnRH antagonist therapies like Merigolix are forecasted to dominate the market, potentially accounting for 70% of the total endometriosis treatment market.

TiumBio Co., Ltd. is dedicated to discovering and developing innovative treatments for rare and incurable diseases. In addition to Merigolix, the company is developing TU2218, an oral immune-oncology therapy, and TU7710, a novel recombinant protein for hemophilia patients.