TOKYO, March 3, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, 'Astellas') today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women..

东京，2024年3月3日/PRNewswire/--Astellas Pharma Inc.（东京证交所：4503，总裁兼首席执行官：冈村直树（Naoki Okamura），“Astellas”）今天宣布，在STARLIGHT™2期3关键研究中，第一名患者服用非佐利坦，这是一种正在研究的口服非激素化合物，用于治疗与日本女性更年期相关的血管舒缩症状（VMS）。

In Japan, two Phase 3 clinical studies are underway. STARLIGHT 2 is evaluating the efficacy and safety of fezolinetant once-daily through 12 weeks. STARLIGHT 3 is evaluating the safety and tolerability of fezolinetant once-daily through 52 weeks.

在日本，正在进行两项3期临床研究。STARLIGHT 2在12周内每天一次评估非佐利坦的疗效和安全性。STARLIGHT 3在52周内每天一次评估非唑啉的安全性和耐受性。

Marci English, Vice President, Head of BioPharma Development, Astellas'VMS associated with menopause affects millions of women in Japan. We are excited the STARLIGHT Phase 3 clinical studies are underway, bringing us one step closer to making this novel, nonhormonal treatment option available in Japan for women experiencing VMS associated with menopause.'.

MarciEnglish是副总裁兼生物制药开发主管，Astellas'VMS与更年期有关，影响着日本数百万女性。我们很兴奋STARLIGHT 3期临床研究正在进行中，这使我们更接近于在日本为患有更年期相关VMS的女性提供这种新颖的非激素治疗选择。

Dosing for the STARLIGHT Phase 3 clinical studies was determined based on available global data, including the STARLIGHT Phase 2b study (NCT05034042) that enrolled 147 patients and completed in 2022. Primary results of STARLIGHT Phase 2b were presented at the Annual Meeting of the Japan Society for Menopause and Women's Health on Dec.3, 2023..

STARLIGHT 3期临床研究的剂量是根据现有的全球数据确定的，包括STARLIGHT 2b期研究（NCT05034042），该研究共招募了147名患者，于2022年完成。STARLIGHT 2b 期研究的初步结果已于 2023 年 12 月 3 日在日本更年期与妇女健康学会年会上公布。

About STARLIGHT 2STARLIGHT 2 (NCT06206408) is a 12-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to evaluate the superiority of fezolinetant versus placebo and assess the safety of fezolinetant in Japanese women experiencing VMS associated with menopause.

关于STARLIGHT 2STARLIGHT 2（NCT06206408）是一项为期12周的随机，双盲，安慰剂对照，平行组，多中心临床研究，旨在评估非唑啉与安慰剂的优越性，并评估非唑啉在经历更年期相关VMS的日本女性中的安全性。

Approximately 390 participants will be randomized to this study with 130 participants per treatment arm (fezolinetant low dose, fezolinetant high dose or placebo). The primary endpoint is mean change in the frequency of VMS from baseline to week 8, with total treatment duration of 12 weeks..

大约390名参与者将被随机分配到这项研究中，每个治疗组有130名参与者（非唑啉坦低剂量，非唑啉坦高剂量或安慰剂）。主要终点是VM频率从基线到第8周的平均变化，总治疗时间为12周。

About STARLIGHT 3STARLIGHT 3 (NCT06206421) is a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to assess the safety and tolerability of fezolinetant in Japanese women experiencing VMS associated with menopause. Approximately 260 participants will be randomized to this study with 130 participants per treatment arm (fezolinetant or placebo).

关于STARLIGHT 3STARLIGHT 3（NCT06206421）是一项为期52周的随机，双盲，安慰剂对照，平行组，多中心临床研究，旨在评估非唑啉在经历更年期相关VMS的日本女性中的安全性和耐受性。大约260名参与者将被随机分配到这项研究中，每个治疗组有130名参与者（非佐林或安慰剂）。

The primary endpoint is frequency and severity of adverse events through 52 weeks..

主要终点是52周内不良事件的频率和严重程度。

About VMSVMS, also known as hot flashes and/or night sweats, are common symptoms of menopause that can have a disruptive impact on women's daily activities and overall quality of life.1,2  Worldwide, more than half of women 40 to 64 years of age experience VMS.3,4 In Japan, about 25% to 37% of women experience these symptoms during or after the menopausal transition.5,6.

关于VMVMs，也称为潮热和/或盗汗，是更年期的常见症状，可能对女性的日常活动和整体生活质量产生破坏性影响[1,2]。在世界范围内，超过一半的40至64岁的女性经历过VMS[3,4]。在日本，约25%至37%的女性在更年期过渡期间或之后会出现这些症状[5,6]。

About FezolinetantFezolinetant is an investigational oral, nonhormonal medicine in clinical development in Japan for the treatment of VMS associated with menopause. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.7,8,9 There is no guarantee the agent will receive regulatory approval in Japan or become commercially available for the uses being investigated..

关于fezolinetantfozolinetant是日本临床开发中的一种研究性口服非激素药物，用于治疗与更年期相关的VMS。VM也被称为潮热或盗汗。Fezolinetant通过阻断神经激肽B（NKB）与kisspeptin/神经激肽/强啡肽（KNDy）神经元的结合，帮助恢复大脑温度控制中心（下丘脑）的平衡以减少潮热和盗汗的数量和强度。7,8,9不能保证该药物将在日本获得监管部门的批准或可用于正在研究的用途。

About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality.

关于AstellasAstellas Pharma Inc.是一家在全球70多个国家开展业务的制药公司。我们正在推动重点领域方法，该方法旨在通过关注生物学和模式，确定持续开发新药的机会，以解决医疗需求未得到满足的疾病。

Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients.

此外，我们还着眼于超越Rx的基础重点，创建Rx+®医疗保健解决方案，将我们的专业知识与外部合作伙伴不同领域的尖端技术相结合。通过这些努力，Astellas站在医疗改革的前沿，将创新科学转化为患者的价值。

For more information, please visit our website at https://www.astellas.com/en..

欲了解更多信息，请访问我们的网站https://www.astellas.com/en

Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties.

注意事项在本新闻稿中，有关当前计划、估计、战略和信念的声明以及其他非历史事实的声明都是关于阿斯特拉斯未来表现的前瞻性声明。这些声明基于管理层目前的假设和信念，并根据目前可获得的信息，涉及已知和未知的风险和不确定性。

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

许多因素可能导致实际结果与前瞻性声明中讨论的结果存在重大差异。这些因素包括但不限于：（i）与药品市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品发布的延迟，（iv）阿斯特拉斯无法有效地营销现有产品和新产品，（v）Astellas无法在竞争激烈的市场上继续有效地研究和开发客户接受的产品，以及（vi）第三方侵犯Astellas的知识产权。

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice..

本新闻稿中包含的有关药品（包括目前正在开发的产品）的信息无意构成广告或医疗建议。