TiumBio Announces Positive Topline Data from Phase 2a Trial of Merigolix in Patients with Moderate to Severe Endometriosis-Associated Pain
2024-05-08
临床2期临床结果免疫疗法
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)
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 pChina 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
[email protected]
Suna Cho, Manager, Corporate Communications & Investor Relations
[email protected]
Da-ye Song, Manager, Corporate Communications & Investor Relations
[email protected]
SOURCE TiumBio
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