2026年美国皮肤病学会年会接受Rezpegaldesleukin的2b期研究数据进行两次口头报告

SAN FRANCISCO

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,

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March 20, 2026

2026年3月20日

/PRNewswire/ -- Nektar Therapeutics (Nasdaq:

/PRNewswire/ -- Nektar Therapeutics (纳斯达克:

NKTR

NKTR

) announced today that data from the ongoing Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata have been accepted for two oral presentations at the 2026 American Academy of Dermatology (AAD) Annual Meeting taking place March 27-31, 2026, in Denver, CO.

）今天宣布，关于雷兹培加尔德斯勒金在特应性皮炎和斑秃方面的正在进行的 2b 期研究数据已被接受，将在 2026 年 3 月 27 日至 31 日于科罗拉多州丹佛市举行的 2026 年美国皮肤病学会 (AAD) 年会上进行两次口头报告。

Rezpegaldesleukin is a novel first-in-class regulatory T (Treg) cell stimulator designed to address the imbalance in the immune system underlying autoimmune disorders and chronic inflammatory conditions. Rezpegaldesleukin works by targeting the IL-2 receptor complex and preferentially stimulating the proliferation of Treg cells without stimulating cytotoxic CD8+ T and CD4+ T cells, which drive autoimmune disease, to restore immune balance..

Rezpegaldesleukin 是一种新型的首创调节性 T (Treg) 细胞刺激剂，旨在解决导致自身免疫疾病和慢性炎症状态的免疫系统失衡问题。Rezpegaldesleukin 通过靶向 IL-2 受体复合物，优先刺激 Treg 细胞的增殖，而不会刺激驱动自身免疫疾病的细胞毒性 CD8+ T 和 CD4+ T 细胞，从而恢复免疫平衡。

Details of the presentations at AAD are as follows:

在AAD的演讲详情如下：

Late-Breaking Research Oral Presentation (Abstract 79863):

最新突破性研究口头报告（摘要编号79863）：

'Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy and Safety Results Following 36-Weeks of Therapy in Severe-to-Very-Severe Alopecia Areata'

新型调节性T细胞增强生物制剂Rezpegaldesleukin：重度至极重度斑秃患者36周治疗后的2b期疗效与安全性结果

Presenter: David Rosmarin, MD, FAAD

讲者：David Rosmarin，医学博士，FAAD

Presentation Date and Time: Saturday, March 28, 2026 from 10:36-10:48 AM MST

演示日期和时间：2026年3月28日星期六上午10:36-10:48（MST）

Session Title: Late-Breaking Research: Session 1

会议标题：最新研究：第一场

Location: Colorado Convention Center, Bellco Theatre 3

地点：科罗拉多会议中心，贝尔科剧院 3

ePoster Oral Presentation (Abstract 73858):

电子海报口头报告（摘要73858）：

'Novel Regulatory T-cell enhancing Biologic Rezpegaldesleukin: Phase 2b Efficacy, Safety, and Baseline Severity–Dependent Treatment Response in Moderate-to-Severe Atopic Dermatitis'

新型调节性T细胞增强生物制剂Rezpegaldesleukin：中重度特应性皮炎的2b期疗效、安全性和基线严重程度依赖性治疗反应

Presenter: Raj Chovatiya, MD, PhD, MSCI, FAAD

主持人：Raj Chovatiya，医学博士，哲学博士，MSCI，FAAD

Presentation Date and Time: Saturday, March 28, 2026 from 11:40 AM-11:45 AM MST

演示日期和时间：2026年3月28日星期六，上午11点40分至上午11点45分（山区标准时间）

Location: Colorado Convention Center, Lobby C, Poster Center 1

地点：科罗拉多会议中心，C大厅，海报中心1

About REZOLVE-AA Phase 2b Study

关于REZOLVE-AA 2b期研究

The REZOLVE-AA (NCT06340360) study enrolled patients with severe-to-very-severe alopecia areata who have not previously been treated with a JAK inhibitor or other biologic. Patients were randomized across two different dose regimens of rezpegaldesleukin or placebo. The trial completed enrollment in February 2025, with patients enrolled across approximately 30 sites globally, with 62% of patients in Poland; 24% in Canada; and 14% in the United States..

REZOLVE-AA（NCT06340360）研究招募了患有严重至极重度斑秃且之前未接受过JAK抑制剂或其他生物制剂治疗的患者。患者被随机分配到两种不同剂量方案的雷泽培尔德斯勒金或安慰剂组。该试验于2025年2月完成招募，患者分布在全球约30个试验点，其中62%的患者来自波兰，24%来自加拿大，14%来自美国。

The primary endpoint was the mean percentage reduction from baseline in the Severity of Alopecia Tool (SALT) score at Week 36. Key secondary endpoints include the proportion of patients that achieved absolute SALT scores of less than or equal to 30, 20, and 10, along with the exploratory endpoint of the Clinical-Reported Outcomes (ClinRO) Eyebrow and Eyelash Score..

主要终点是第36周时脱发严重程度工具（SALT）评分相对于基线的平均百分比降幅。关键次要终点包括达到绝对SALT评分小于或等于30、20和10的患者比例，以及探索性终点临床报告结局（ClinRO）眉毛和睫毛评分。

Enrollment criteria in the study included a diagnosis of severe-to-very-severe alopecia areata (≥ 50% scalp involvement) as measured using the SALT score at both screening and randomization. Patients who experienced an unstable course of alopecia areata over the last 6 months per investigator assessment or had inadequate washout of prior alopecia areata treatments (within 8 weeks) were excluded from the study.

研究中的纳入标准包括在筛选和随机分组时使用SALT评分测量诊断为重度至极重度斑秃（头皮受累≥50%）。根据研究者评估，过去6个月中斑秃病程不稳定的患者或既往斑秃治疗洗脱期不足（8周内）的患者被排除在研究之外。

Patients with diffuse alopecia and other forms of alopecia were also excluded. Patient randomization was stratified based on baseline disease severity as measured by a SALT score of ≥50 or less than 95% (severe) and ≥95 (very severe). Enrollment of very severe patients was capped at 25%..

患有弥漫性脱发和其他形式脱发的患者也被排除在外。患者随机化根据基线疾病严重程度进行分层，基线疾病严重程度由SALT评分衡量，≥50或小于95%（严重）和≥95（非常严重）。非常严重患者的入组比例被限制在25%。

About REZOLVE-AD Phase 2b Study

关于REZOLVE-AD第二b阶段研究

The global 393-patient Phase 2b study was conducted in patients with moderate to severe atopic dermatitis. Patients were randomized (3:3:3:2) to receive subcutaneous treatment with three doses of rezpegaldesleukin: a high dose of 24 µg/kg every two weeks (Q2W), a middle dose of 18 µg/kg every two weeks (Q2W), and a low dose of 24 µg/kg every four weeks (Q4W), or placebo Q2W.

全球393名患者参与的2b期研究是在中度至重度特应性皮炎患者中进行的。患者被随机分配（3:3:3:2）接受三种剂量的rezpegaldesleukin皮下治疗：高剂量组每两周一次24 µg/kg（Q2W），中剂量组每两周一次18 µg/kg（Q2W），低剂量组每四周一次24 µg/kg（Q4W），或每两周一次安慰剂（Q2W）。

The primary endpoint and secondary endpoints were assessed at Week 16. Following the induction period, rezpegaldesleukin-treated patients who achieved EASI percent reductions of at least 50 were re-randomized (1:1) to continue at the same dose level on a Q4W or Q12W regimen through Week 52 in a blinded maintenance period.

主要终点和次要终点在第16周进行了评估。诱导期结束后，达到EASI百分比至少降低50的rezpegaldesleukin治疗患者被重新随机分配（1:1），在双盲维持期继续以相同剂量水平按照每4周一次（Q4W）或每12周一次（Q12W）的方案治疗至第52周。

Placebo patients with EASI percent score reductions of at least 50 continue to receive placebo Q4W..

EASI 百分比评分降低至少 50 的安慰剂患者继续每 4 周接受一次安慰剂。

The REZOLVE-AD trial was initiated in October 2023 and enrolled patients across approximately 110 sites globally. Enrollment included 68% of patients treated in Europe, 16% in the United States, 11% in Canada, and 5% in Australia. Key eligibility criteria included a minimum EASI score of 16.0, Body Surface Area (BSA) involvement of at least 10%, and a vIGA-AD score of at least 3 at screening and randomization..

REZOLVE-AD 试验于 2023 年 10 月启动，并在全球约 110 个地点招募了患者。其中 68% 的患者在欧洲接受治疗，16% 在美国，11% 在加拿大，5% 在澳大利亚。关键的入组标准包括筛选和随机分组时 EASI 评分至少为 16.0、体表面积 (BSA) 受累至少 10%，以及 vIGA-AD 评分至少为 3。

About Rezpegaldesleukin

关于Rezpegaldesleukin

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. Rezpegaldesleukin is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions.

自身免疫和炎症性疾病会导致免疫系统错误地攻击并损害人体内的健康细胞。机体自我耐受机制的失效会促使致病性T淋巴细胞的形成，从而发动这种攻击。雷泽培度司他（Rezpegaldesleukin）是一种潜在的首创解决方案治疗药物，可能解决许多自身免疫和炎症性疾病患者体内潜在的免疫系统失衡问题。

It targets the interleukin-2 receptor complex in the body to stimulate proliferation of immune-modulating cells known as regulatory T cells. By activating these cells, rezpegaldesleukin 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，刺激被称为调节性T细胞的免疫调节细胞增殖。通过激活这些细胞，雷泽培尔德斯勒金可能起到使免疫系统恢复平衡的作用。

In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

2025年2月，美国食品药品监督管理局（FDA）授予了rezpegaldesleukin快速通道资格，用于治疗12岁及以上中至重度特应性皮炎的成人和儿童患者，这些患者的疾病通过局部处方疗法无法得到充分控制，或者当这些疗法不适用时。

In July 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg..

2025年7月，FDA授予了rezpegaldesleukin快速通道资格，用于治疗严重斑秃（AA）的成人和12岁及以上且体重至少40公斤的儿科患者。

Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is wholly owned by Nektar Therapeutics.

Rezpegaldesleukin 正在被开发为用于多种自身免疫和炎症性疾病的自我注射药物。该药物由 Nektar Therapeutics 全资拥有。

About

关于

Nektar Therapeutics

Nektar Therapeutics

Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in one Phase 2b clinical trial in atopic dermatitis, one Phase 2b clinical trial in alopecia areata, and one Phase 2 clinical trial in Type 1 diabetes mellitus.

Nektar Therapeutics是一家临床阶段的生物技术公司，专注于开发针对自身免疫和慢性炎症疾病中潜在免疫功能障碍的治疗方法。Nektar的主要候选产品rezpegaldesleukin（REZPEG，或NKTR-358）是一种新型的、首创新药类别的调节性T细胞刺激剂，目前正在一项针对特应性皮炎的2b期临床试验、一项针对斑秃的2b期临床试验以及一项针对1型糖尿病的2期临床试验中进行评估。

Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422..

Nektar的管线还包括一种临床前双价肿瘤坏死因子受体II型（TNFR2）抗体和双特异性项目，NKTR-0165和NKTR-0166，以及一种改良的造血集落刺激因子（CSF）蛋白，NKTR-422。

Nektar is headquartered in San Francisco, California. For further information, visit

Nektar总部位于加利福尼亚州旧金山。欲了解更多信息，请访问

www.nektar.com

www.nektar.com

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Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警告性说明

This press release contains forward-looking statements which can be identified by words such as: 'could,' 'develop,' 'potential,' 'target,' 'address,' 'may' 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, NKTR-0165, NKTR-0166, and NKTR-422.

本新闻稿包含前瞻性陈述，这些陈述可以通过诸如“可能”、“开发”、“潜力”、“目标”、“解决”、“或许”以及类似的对未来时期的引用加以识别。前瞻性陈述的例子包括但不限于关于雷泽帕尔德斯勒金、NKTR-0165、NKTR-0166 和 NKTR-422 的治疗潜力和未来开发计划的陈述。

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，也不能保证未来的表现。相反，它们仅基于我们当前对业务未来、未来计划和战略、预期事件和趋势、经济状况及其他未来条件的信念、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.

由于前瞻性陈述涉及未来，它们受到固有的不确定性、风险和难以预测的环境变化的影响，其中许多是我们无法控制的。我们的实际结果可能与前瞻性陈述中所示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, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier prec.

因此，您不应依赖任何这些前瞻性陈述。可能导致我们实际结果与前瞻性陈述中所示有重大差异的重要因素包括但不限于：(i) 我们关于rezpegaldesleukin、NKTR-0165、NKTR-0166和NKTR-422的治疗潜力的陈述基于临床前和临床研究结果及观察，并且随着研发的继续可能会发生变化；(ii) rezpegaldesleukin、NKTR-0165、NKTR-0166和NKTR-422为研究性药物，其进一步的研发仍面临重大风险，包括未来临床研究中可能出现负面的安全性和有效性结果（尽管早期研究结果为阳性）。

For Investors:

对于投资者：

Vivian Wu

吴薇薇

628-895-0661

628-895-0661

[email protected]

电子邮件地址

Corey Davis, Ph.D.

科里·戴维斯，博士

LifeSci Advisors

生命科学顾问

212-915-2577

212-915-2577

[email protected]

电子邮件地址

For Media:

媒体：

Jonathan Pappas

乔纳森·帕帕斯

LifeSci Communications

生命科学传播

857-205-4403

857-205-4403

[email protected]

电子邮件地址

SOURCE Nektar Therapeutics

来源：Nektar Therapeutics

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