SAN FRANCISCO, March 5, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata..

旧金山，2024年3月5日/PRNewswire/-Nektar Therapeutics（Nasdaq:NKTR），一家开发治疗自身免疫性疾病药物的生物技术公司，今天宣布开始其2b期临床试验，评估严重至非常严重的斑秃患者的rezpegaldesleukin。。

Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional T reg cells and engaging multiple immunoregulatory pathways.

Rezpegaldesleukin（REZPEG）是一种新型激动性T调节细胞生物学制剂，旨在通过直接扩增功能性T reg细胞和参与多种免疫调节途径来抑制炎症反应并同时恢复免疫平衡。

'The start of this Phase 2b study is another significant milestone for Nektar as we advance REZPEG, a potentially transformative new mechanism for alopecia areata and other auto-immune disorders,' said Mary Tagliaferri, M.D., Chief Medical Officer at Nektar Therapeutics. 'Alopecia areata is a disease where a patient's own immune system attacks hair follicles and the resulting hair loss can be devastating for patients.  Current treatments available have high relapse rates and carry potential safety challenges.

Nektar Therapeutics首席医学官玛丽·塔格里亚费里（MaryTagliaferri）医学博士说：“随着我们推进REZPEG，这项2b期研究的开始是Nektar的另一个重要里程碑，REZPEG是斑秃和其他自身免疫性疾病的潜在变革性新机制。”斑秃是一种患者自身免疫系统攻击毛囊的疾病，由此导致的脱发可能对患者造成毁灭性影响。目前可用的治疗方法复发率很高，并存在潜在的安全挑战。

As a result, there is a high unmet need for durable and well-tolerated treatment options that target the underlying dysfunction of the immune system in these patients. We believe there's an opportunity for REZPEG to emerge as a novel biologic mechanism for alopecia patients and we look forward to our topline data from this study expected in the first half of 2025.'.

因此，针对这些患者潜在的免疫系统功能障碍，对持久且耐受性良好的治疗方案的需求尚未得到满足。我们相信REZPEG有机会成为脱发患者的新型生物学机制，我们期待着2025年上半年这项研究的最终数据。”。

Nektar's global, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b study will investigate the efficacy and safety of REZPEG in 84 participants with severe to very severe alopecia areata over a 36-week induction treatment period. The induction treatment period will compare two different dosing regimens of REZPEG against placebo.

Nektar的全球，随机，双盲，安慰剂对照，剂量范围2b期研究将调查REZPEG在36周诱导治疗期间对84名严重至非常严重斑秃患者的疗效和安全性。诱导治疗期将比较REZPEG与安慰剂的两种不同给药方案。

Participants will be followed for an additional 24 weeks after the end of the treatment period to evaluate durability. Initial results from the study are anticipated in the first half of 2025..

在治疗期结束后，将对参与者进行额外的24周随访，以评估其耐久性。预计该研究的初步结果将于2025年上半年公布。。

The primary efficacy endpoint will evaluate mean percent improvement in the Severity of Alopecia Tool (SALT) at week 36. Secondary endpoints include proportion of participants with greater than or equal to 50% reduction in SALT at week 36 and other assessed timepoints and mean percent improvement in SALT at other assessed timepoints..

主要疗效终点将评估第36周脱发工具（SALT）严重程度的平均改善百分比。次要终点包括在第36周和其他评估时间点盐减少大于或等于50%的参与者比例，以及在其他评估时间点盐的平均改善百分比。。

About Alopecia Areata

关于斑秃

The lifetime incidence of alopecia areata is 2% in both men and women.1 Nearly 6.7 million people in the U.S. and 160 million worldwide develop alopecia areata in their lifetime. About 700,000 people in the U.S. currently have some form of alopecia areata.2 It is often associated with other auto-immune conditions as well as depression and anxiety.1 The disease has a tremendous impact on quality of life for patients.3 Available therapies for alopecia are not durable and have high relapse rates and there is an urgent unmet medical need for novel, more effective therapies for patients.    .

男性和女性的斑秃终生发病率均为2%。1美国近670万人和全球1.6亿人一生中患有斑秃。目前，美国约有70万人患有某种形式的斑秃。2斑秃通常与其他自身免疫疾病以及抑郁和焦虑有关。1该疾病对患者的生活质量产生了巨大影响。3现有的脱发治疗方法不持久，复发率高，迫切需要新的治疗方法，对患者进行更有效的治疗。。

About REZPEG

关于REZPEG

Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions.

自身免疫性和炎症性疾病会导致免疫系统错误地攻击和破坏人体内的健康细胞。身体自我耐受机制的失败使得能够形成进行这种攻击的致病性T淋巴细胞。REZPEG是一种潜在的一流分辨率治疗药物，可以解决许多自身免疫和炎症患者潜在的免疫系统失衡问题。

It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance..

它靶向体内的白细胞介素-2受体复合物，以刺激称为调节性T细胞的强大抑制性免疫细胞的增殖。通过激活这些细胞，REZPEG可能会使免疫系统恢复平衡。。

REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. In addition to this clinical trial in patients with severe to very severe alopecia areata, REZPEG is also being evaluated in a Phase 2b study in the treatment of adult patients with moderate-to-severe atopic dermatitis (REZOLVE-AD; NCT06136741).

REZPEG是一种用于多种自身免疫性和炎性疾病的自我给药注射液。除了这项针对严重至非常严重斑秃患者的临床试验外，REZPEG还在一项2b期研究中进行评估，用于治疗中度至重度特应性皮炎的成年患者（REZOLVE-AD；NCT06136741）。

REZPEG is wholly-owned by Nektar Therapeutics..

REZPEG是Nektar Therapeutics的全资子公司。。

About Nektar Therapeutics

关于Nektar Therapeutics

Nektar Therapeutics is a biotechnology company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama.

Nektar Therapeutics是一家生物技术公司，拥有强大的全资肿瘤学和免疫学研究药物研发渠道，以及经批准的合作药物组合。Nektar总部位于加利福尼亚州旧金山，另外在阿拉巴马州亨茨维尔也有业务。

Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com..

有关该公司及其药物开发计划和能力的更多信息，请访问http://www.nektar.com..

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release contains forward-looking statements which can be identified by words such as: 'will,' 'expect,' 'develop,' 'potential,' 'advance,' 'anticipate,' and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for, rezpegaldesleukin.

本新闻稿包含前瞻性陈述，这些陈述可以通过以下词语来识别：“将”、“期望”、“发展”、“潜力”、“前进”、“预期”，以及对未来时期的类似引用。前瞻性声明的例子包括关于rezpegaldesleukin的治疗潜力和未来发展计划的声明。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions.

前瞻性陈述既不是历史事实，也不是未来表现的保证。相反，它们仅基于我们目前对业务未来、未来计划和战略、预期事件和趋势、经济和其他未来状况的信念、期望和假设。

Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements.

由于前瞻性陈述与未来有关，因此它们受到难以预测的固有不确定性、风险和环境变化的影响，其中许多不在我们的控制范围内。我们的实际结果可能与前瞻性声明中指出的结果存在重大差异。

Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and the risk of fa.

因此，您不应该依赖这些前瞻性陈述。可能导致我们的实际结果与前瞻性陈述中指出的结果存在重大差异的重要因素包括：（i）我们关于rezpegaldesleukin治疗潜力的陈述是基于临床前和临床发现和观察，随着研究和开发的继续，可能会发生变化；（ii）rezpegaldesleukin是一种研究药物，对该候选药物的持续研究和开发面临重大风险，包括未来临床研究中的负面安全性和有效性发现（尽管早期临床前和临床研究中有积极发现）；（iii）rezpegaldesleukin正在临床开发和fa的风险。

Contact:

联系人：

For Investors:

对于投资者：

Vivian Wu of Nektar Therapeutics628-895-0661

Nektar Therapeutics的Vivian Wu 628-895-0661

For Media:

对于媒体：

David Rosen of Argot Partners(212) 600-1902david.rosen@argotpartners.com

Argot Partners的David Rosen（212）600-1902david.rosen@argotpartners.com

Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K., Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current understanding and management. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 20: 59-90. https://doi.org/10.1111/ddg.14689

Lintzeri，D.A.，Constantinou，A.，Hillmann，K.，Ghoreschi，K.，Vogt，A.和Blume-Peytavi，U.（2022），斑秃-当前的理解和管理。JDDG:Journal der Deutschen Dermatologischen Gesellschaft，20:59-90https://doi.org/10.1111/ddg.14689

National Alopecia Areata Foundation

国家斑秃基金会

Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia Areata: Burden of Disease, Approach to Treatment, and Current Unmet Needs. Clin Cosmet Investig Dermatol. 2023;16:803-820https://doi.org/10.2147/CCID.S376096

Alhanshali L，Buontempo MG，Lo Sicco KI，Shapiro J.斑秃：疾病负担，治疗方法和当前未满足的需求。临床Cosmet Investig Dermatol。2023年；16： 803-820https://doi.org/10.2147/CCID.S376096

SOURCE Nektar Therapeutics

来源Nektar Therapeutics