Nektar Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body to stimulate proliferation of inhibitory immune cells known as regulatory T cells (Tregs).

Nektar Therapeutics今天宣布，美国食品和药物管理局 (FDA) 已授予 rezpegaldesleukin 快速通道资格，用于治疗重度至极重度斑秃 (AA)，适用于 12 岁及以上、体重至少 40 公斤的成人和儿童患者。Rezpegaldesleukin 是一种研究性生物疗法，靶向体内白细胞介素-2 受体复合物，以刺激被称为调节性 T 细胞 (Tregs) 的抑制性免疫细胞的增殖。

Results from multiple clinical trials showed that rezpegaldesleukin safely and dose-dependently increased Tregs..

多个临床试验结果显示，rezpegaldesleukin 能够安全且剂量依赖性地增加 Tregs。

'We are pleased that rezpegaldesleukin has been granted Fast Track designation for the treatment of alopecia areata, adding to its Fast Track designation in atopic dermatitis,' said

“我们很高兴雷泽培加尔德斯勒金已被授予快速通道资格，用于治疗斑秃，此前它已获得特应性皮炎的快速通道资格，”

Jonathan Zalevsky

乔纳森·扎列夫斯基

, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. 'Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches that could treat the underlying pathogenesis of this disorder. We remain on track to announce topline data in December from our ongoing REZOLVE-AA Phase .

，博士，Nektar高级副总裁兼首席研发官。'斑秃是一种慢性、系统性、免疫介导的炎症性疾病，迫切需要能够治疗该疾病潜在病原机制的新型方法。我们仍在按计划于12月发布正在进行的REZOLVE-AA阶段的初步数据。'

2b

2b

study for rezpegaldesleukin in alopecia areata, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational program following the completion of Phase 2.'

研究雷兹培加尔地塞白介素治疗斑秃，并期待在二期临床试验完成后，尽快与该机构合作开展潜在的注册计划。

The goal of the FDA's Fast Track process is to ensure that important new treatments reach patients as quickly as possible. The designation is granted to investigational therapies that treat serious conditions and have the potential to address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling review and priority review..

FDA的快速通道流程的目标是确保重要的新疗法尽快送达患者。该指定授予治疗严重疾病且具有满足未满足医疗需求潜力的在研疗法。获得快速通道指定的候选药物有资格与FDA进行更频繁的会议和书面互动，以讨论候选药物的开发计划以及可能符合滚动审查和优先审查的资格。

About REZOLVE-AA

关于REZOLVE-AA

The REZOLVE-AA (

REZOLVE-AA (

NCT06340360

NCT06340360

) study enrolled approximately 90 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 primary efficacy endpoint will evaluate the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period.

该研究招募了大约90名严重至极重度斑秃患者，这些患者之前未接受过JAK抑制剂或其他生物制剂的治疗。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。主要疗效终点将评估在36周诱导期结束时，脱发严重程度工具（SALT）评分的平均百分比变化。

Secondary endpoints include the proportion of participants with greater than or equal to 50% reduction in SALT score at week 36 and other assessed timepoints, the mean percent improvement in SALT score at other assessed timepoints, and the proportion of patients achieving SALT-20 (an absolute SALT score of less than or equal to 20).

次要终点包括在第36周及其它评估时间点，SALT评分减少大于或等于50%的参与者比例、其他评估时间点SALT评分的平均百分比改善，以及达到SALT-20（绝对SALT评分小于或等于20）的患者比例。

The Company expects to share these results in .

公司预计将在分享这些结果。

December 2025

2025年12月

This trial was initiated in March 2024. Patients were enrolled across approximately 30 sites globally with: 62% enrolled in Poland; 24% enrolled in Canada; and 14% enrolled in the

该试验于2024年3月启动。患者在全球大约30个地点注册，其中：62%在波兰注册；24%在加拿大注册；14%在

United States

美国

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 were excluded from the study.

研究中的入组标准包括在筛查和随机分组时，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 the SALT score..

弥漫性脱发和其他形式的脱发患者也被排除在外。患者随机化根据基线疾病严重程度（由SALT评分衡量）进行分层。

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，从而发起这种攻击。雷泽培达珠单抗是一种潜在的首创解决方案药物，可能解决许多自身免疫和炎症性疾病患者的潜在免疫系统失衡问题。

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

它靶向体内白细胞介素-2受体复合物，刺激被称为调节性T细胞的强大抑制性免疫细胞的增殖。通过激活这些细胞，雷兹培加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 who weigh at least 40 kilograms 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、体重至少40公斤、中度至重度特应性皮炎的成人和儿童患者，这些患者的疾病无法通过局部处方疗法充分控制，或在这些疗法不适用时使用。

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。它完全由 Nektar Therapeutics 拥有。

About Alopecia Areata

关于斑秃

Alopecia areata is a disease where a patient's own immune system attacks hair follicles resulting in hair loss.

斑秃是一种自身免疫系统攻击毛囊导致脱发的疾病。

2

2

The lifetime incidence of alopecia areata is 2% in both men and women.

男女斑秃的终生发病率均为2%。

2

2

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.

美国约有670万人、全球约有1.6亿人在其一生中会患上斑秃。美国目前约有70万人患有某种形式的斑秃。

It is often associated with other auto-immune conditions as well as depression and anxiety.

它常与其他自身免疫性疾病以及抑郁和焦虑相关联。

The disease has a tremendous impact on quality of life for patients.

这种疾病对患者的生活质量有极大的影响。

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.

脱发的现有疗法并不持久，复发率高，患者急需更有效的新疗法来满足医疗需求。

About Nektar Therapeutics

关于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 two Phase .

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、首例调节性T细胞刺激剂，目前正在两项二期临床试验中进行评估。

clinical trials, one in atopic dermatitis and one in alopecia areata. 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.

临床试验，一项针对特应性皮炎，另一项针对斑秃。Nektar的管线还包括一种处于临床前阶段的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, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials..

Nektar 与多家合作伙伴一起，也正在多项正在进行的临床试验中评估 NKTR-255（一种研究性的 IL-15 受体激动剂），该药物旨在增强免疫系统对抗癌症的自然能力。