• The study (NCT05138562) met its primary endpoint of change of dysmenorrhea (menstrual pain) score from baseline to 12 weeks compared to placebo across all tested doses (120 mg, 240 mg, and 320 mg) 
• Merigolix is expected to emerge as a best-in-class treatment based on its excellent pain reduction and favorable safety profiles among gonadotropin-releasing hormone (GnRH) antagonists
• Positive results are also anticipated in ongoing clinical trials conducted in another disease such as uterine fibroids

BOSTON and SEONGNAM, South Korea, May 8, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced positive topline results from its Phase 2a clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in patients with moderate to severe endometriosis-associated pain. The trial achieved its primary endpoint of reducing dysmenorrhea scores compared to placebo across all three dose groups, demonstrating a statistically significant difference (120mg group p=0.044, 240mg group p=0.001, 320mg group p<0.001).

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 randomized to receive either Merigolix 120 mg, Merigolix 240 mg, Merigolix 320 mg, or a placebo once daily (QD) 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.

As a result of that, Merigolix achieved statistically significant and clinically meaningful improvements in mean dysmenorrhea scores from baseline compared to the placebo group at all tested doses: -4.3 point at the 120 mg dose (p=0.044), -5.4 point at the 240 mg dose (p=0.001), and -6.2 point at the 320 mg dose (p<0.001), while the placebo group reported -2.7 point.

Merigolix was generally well tolerated, 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. 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.

Likewise, a company official stated, "In addition to endometriosis, there is high potential to apply Merigolix to another women's disease such as uterine fibroids, and positive results are expected from ongoing clinical trials of Merigolix in China and Republic of Korea. Consequently, we anticipate that subsequent clinical development and business expansion of Merigolix will accelerate."

Merigolix is an orally active non-peptide GnRH antagonist for the treatment of endometriosis and uterine fibroids. Merigolix offers improved convenience of administration and safety compared to conventional GnRH agonists.

According to GlobalData, the endometriosis market will reach approximately $2.7 billion in 7 major countries (US, Germany, France, Italy, UK, Spain, Japan) by 2030. It is forecasted that GnRH antagonist therapies will replace existing treatments, accounting for about 70% of the total endometriosis market.

About Endometriosis

Endometriosis is a disorder in which the endometrial tissue that line the inside of the uterus grows out the uterus and is known to cause severe pelvic pain, menstrual pain, lower abdominal pain, and infertility which occurs in about 10-30% of women in childbearing age. It is estimated to affect approximately 200 million patients worldwide.

About TiumBio Co., Ltd.

TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: Merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development.

Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel recombinant FVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors.

With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn.

Contacts:

Junseok Jang, Head of Corporate Communications & Investor Relations
junseokjang@tiumbio.com 

Suna Cho, Manager, Corporate Communications & Investor Relations
sunacho@tiumbio.com 

Da-ye Song, Manager, Corporate Communications & Investor Relations
dayesong@tiumbio.com