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)

这项研究（NCT05138562）在所有测试剂量（120毫克、240毫克和320毫克）中，与安慰剂相比，达到了痛经（月经疼痛）评分从基线到12周变化的主要终点

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

在促性腺激素释放激素（GnRH）拮抗剂中，Merigolix具有出色的止痛效果和良好的安全性，有望成为一流的治疗药物

Positive results are also anticipated in ongoing clinical trials conducted in another disease such as uterine fibroids

正在进行的针对另一种疾病（例如子宫肌瘤）的临床试验也有望取得积极结果

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.

波士顿和韩国城南，2024年5月8日/PRNewswire/--TiumBio Co.，Ltd.（KOSDAQ:321550），一家临床阶段的生物制药公司，专注于发现和开发针对罕见和不可治愈疾病患者的创新疗法，宣布其口服促性腺激素释放激素（GnRH）受体拮抗剂Merigolix在中重度子宫内膜异位症相关疼痛患者中的2a期临床试验取得了积极的topline结果。

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)..

该试验在所有三个剂量组中均达到了与安慰剂相比降低痛经评分的主要终点，显示出统计学上的显着差异（120mg组p=0.04420mg组p=0.001，320mg组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.

该研究在五个欧洲国家招募了86名患有中度至重度子宫内膜异位症相关疼痛的女性患者，以评估Merigolix在子宫内膜异位症中的疗效和安全性。患者被随机分配接受Merigolix 120 mg，Merigolix 240 mg，Merigolix 320 mg或安慰剂，每天一次（QD），持续12周。

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..

通过使用数字评定量表（NRS）测量过去一个月的平均痛经评分，评估子宫内膜异位症相关疼痛从基线到治疗12周的变化。。

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..

因此，与安慰剂组相比，Merigolix在所有测试剂量下的平均痛经评分均比基线有统计学意义和临床意义的改善：-120 mg剂量为4.3分（p=0.044），240 mg剂量为-5.4分（p=0.001），320 mg剂量为-6.2分（p<0.001），而安慰剂组报告为-2.7分。。

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.

与先前的研究一致，Merigolix通常耐受性良好，没有严重的治疗相关不良事件。研究人群中最常见的不良事件是潮热，头痛和恶心。

'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.

“尽管每组规模较小，每组约有20名患者，但在2a期临床试验中，与安慰剂相比，Merigolix在所有剂量下均显示出统计学上显着的疗效。TiumBio首席执行官、MBA博士Hun Taek Kim说，这项临床试验证实，与其他GnRH拮抗剂相比，Merigolix在减少痛经和确保安全性方面取得了优异的临床效果。

'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..

“既然这项概念验证研究支持了Merigolix的潜力，我们的目标是将Merigolix开发成为子宫内膜异位症患者的最佳治疗方法，”他补充道。。

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.'.

同样，一位公司官员表示，“除了子宫内膜异位症外，将Merigolix应用于另一种女性疾病（如子宫肌瘤）的潜力很大，预计在中国和韩国正在进行的Merigolix临床试验将取得积极成果。因此，我们预计Merigolix随后的临床开发和业务扩展将加速。”。

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.

Merigolix是一种口服活性非肽GnRH拮抗剂，用于治疗子宫内膜异位症和子宫肌瘤。与传统的GnRH激动剂相比，Merigolix提供了更好的给药便利性和安全性。

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..

根据GlobalData的数据，到2030年，7个主要国家（美国、德国、法国、意大利、英国、西班牙、日本）的子宫内膜异位症市场将达到约27亿美元。据预测，GnRH拮抗剂疗法将取代现有疗法，约占子宫内膜异位症总市场的70%。。

About Endometriosis

关于子宫内膜异位症

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..

子宫内膜异位症是一种疾病，其中排列在子宫内部的子宫内膜组织长出子宫，已知会引起严重的骨盆疼痛，月经疼痛，下腹痛和不孕症，约有10-30%的育龄妇女发生这种疾病。据估计，全球约有2亿患者受到影响。。

About TiumBio Co., Ltd.

关于TiumBio有限公司

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..

TiumBio（Kosdaq:321550）是一家临床阶段的生物制药公司，专注于为罕见和无法治愈的疾病患者发现和开发创新疗法。它的使命是通过我们的科学扩大人类的希望和幸福。TiumBio拥有三个领先的管道资产：Merigolix（代号：TU2670），TU2218和TU7710，都处于临床开发的各个阶段。。

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.

Merigolix是一种每日一次的口服GnRH受体拮抗剂，正在开发用于治疗子宫内膜异位症和子宫肌瘤，正在进行全球2期临床试验。TU2218是针对TGF-β和VEGF途径的一流口服免疫肿瘤学疗法，与免疫检查点抑制剂联合使用可提高癌症患者的反应率。

TU7710 is a novel recombinant FVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors..

TU7710是一种新型重组FVIIa，旨在延长其半衰期，以便为使用抑制剂的血友病患者提供更多的临床益处。。

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.

凭借其在药物开发方面的专业知识，TiumBio致力于发现和开发创新疗法，以减轻衰弱疾病的负担。欲了解更多信息，请访问我们的网站www.tiumbio.com/en，并通过LinkedIn与我们联系。