– Dose-Dependent Efficacy Reported Across All Endpoints for REZPEG Demonstrating a Rapid Onset of Action and Continuing Benefit for 36 Weeks After 12-Week Treatment Period –

-REZPEG所有终点报告的剂量依赖性疗效显示，在12周的治疗期后，36周内迅速起效并持续获益-

– New Data Presented Show Encouraging Proportion of Patient-Reported Responder Outcomes for DLQI and POEM Endpoints –

-提供的新数据显示DLQI和POEM终点患者报告的应答者结果的比例令人鼓舞-

SAN FRANCISCO, Oct. 13, 2023  /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced new data for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, in patients with atopic dermatitis (AD) at the 2023 European Academy of Dermatology and Venereology (EADV) Congress.

旧金山，2023年10月13日/PRNewswire/-Nektar Therapeutics（纳斯达克股票代码：NKTR）今天公布了rezpegaldesleukin（REZPEG）的新数据，REZPEG是一流的选择性调节性T细胞（Treg）治疗患者特应性皮炎（AD）在2023年欧洲皮肤性病学会（EADV）大会上。

These data were presented by Dr. Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Director of Clinical Research and Contact Dermatitis in a late-breaking oral presentation..

这些数据由乔治华盛顿大学医学与健康科学学院皮肤病学教授乔纳森·西尔弗伯格博士和临床研究与接触性皮炎主任在最新的口头报告中提出。。

'Data from this presentation demonstrate consistent benefit with REZPEG across multiple clinician and patient-reported outcomes, which were maintained through 36 weeks after treatment ended,' said Dr. Jonathan Silverberg. 'The sustained post-treatment benefit observed with REZPEG has the potential to alter the need for frequent maintenance dosing for patients with atopic dermatitis.

Jonathan Silverberg博士说：“来自这个报告的数据表明REZPEG在多个临床医生和患者报告的结果中持续获益，这些结果在治疗结束后36周内保持不变。”用REZPEG观察到的持续的治疗后益处有可能改变特应性皮炎患者频繁维持剂量的需要。

Together with the observed safety profile, these promising results potentially open the door for a new therapeutic class.'.

结合观察到的安全性，这些有希望的结果可能为新的治疗类别打开大门。

In the Phase 1b study, patients with moderate-to-severe AD that were treated with REZPEG showed dose-dependent improvements in Eczema Area and Severity Index (EASI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12 weeks of treatment compared to placebo, which were sustained post-treatment over an additional 36 weeks.

在1b期研究中，用REZPEG治疗的中重度AD患者在湿疹面积和严重程度指数（EASI），经验证的研究者全面评估（vIGA），体表面积（BSA）和瘙痒数字评分量表（NRS）超过12周的治疗相比，安慰剂，持续治疗后超过36周。

At the highest studied dose, the proportion of Daily Life Quality Index (DLQI) responders was 75% and the proportion of Patient Oriented Eczema Measure (POEM) responders was 65% at week 12. The proportion of responders were generally sustained after treatment ended through the 36-week follow-up. This durability highlights REZPEG's disease remittive potential..

在研究剂量最高时，12周时日常生活质量指数（DLQI）应答者比例为75%，患者导向湿疹测量（POEM）应答者比例为65%。在治疗结束后的36周随访中，应答者的比例通常持续。这种耐久性突出了REZPEG的疾病缓解潜力。。

REZPEG was well tolerated with no patients in the REZPEG groups experiencing severe, serious, or fatal adverse events, and no anti-REZPEG antibodies were detected. Pharmacodynamic data observed in the Phase 1b study corroborate the clinical efficacy signal observed in patients. Compared with placebo, there were sustained increases in absolute numbers of circulating total (FoxP3+CD25+) and CD25bright Tregs in the REZPEG treatment arms.

REZPEG耐受性良好，REZPEG组中没有患者经历严重，严重或致命的不良事件，并且未检测到抗REZPEG抗体。在1b期研究中观察到的药效学数据证实了在患者中观察到的临床功效信号。与安慰剂相比，REZPEG治疗组的循环总数（FoxP3+CD25+）和CD25bright Tregs的绝对数量持续增加。

The peak increase in CD25bright Treg number was 10-fold above baseline in the 24 µg/kg group..

在24μg/kg组中，CD25bright Treg数量的峰值增加比基线高10倍。。

Based on these data, the company is initiating two Phase 2 studies in atopic dermatitis and in alopecia areata. These trials are expected to initiate in October of this year and in early 2024, respectively. The trial design for the study in patients with moderate-to-severe atopic dermatitis was presented in an ePoster at EADV earlier this week..

基于这些数据，该公司正在启动特应性皮炎和斑秃的两项2期研究。这些试验预计将分别于今年10月和2024年初开始。本周早些时候，EADV的ePoster介绍了中重度特应性皮炎患者的试验设计。。

'The findings presented today confirm our previously-reported data demonstrating the efficacy and rapid onset of action of REZPEG and continue to reinforce the promise of REZPEG as a novel therapeutic for patients with moderate-to-severe atopic dermatitis,' said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar.

Jonathan Zalevsky博士说：“今天提出的研究结果证实了我们之前报道的数据，证明了REZPEG的有效性和快速起效，并继续加强REZPEG作为中重度特应性皮炎患者新型治疗药物的前景。”Nektar高级副总裁兼首席研发官。

'We look forward to advancing the program into our robust Phase 2b study in this indication and exploring its therapeutic potential in other autoimmune indications, including alopecia areata.'.

“我们期待在这项适应症中将该计划推进到我们强大的2b期研究中，并探索其在其他自身免疫适应症（包括斑秃）中的治疗潜力。”。

Highlight of the new patient-reported outcomes for the Phase 1b study in atopic dermatitis presented at EADV 2023 for the first time:

EADV 2023首次提出特应性皮炎1b期研究新患者报告结果的亮点：

Proportion of Patients Who Achieved a DLQI Greater than or Equal to a 4-point Reduction from Baseline (NRI* calculation)

达到DLQI大于或等于基线降低4分的患者比例（NRI*计算）

Study Arm

学习手臂

12 weeks

12周

48 weeks

48周

Placebo

安慰剂

30 %

30 %

33 %

33 %

12 μg/kg

12μg/kg

46 %

46 %

25 %

25 %

24 μg/kg

24μg/kg

75%(p = 0.0426)

75%（p 0.0426）

56 %

56 %

*NRI: non-responder imputation

*NRI：无应答者插补

Proportion of Patients Who Achieved a POEM Greater than or Equal to a 4-point Reduction from Baseline (NRI* calculation)

达到POEM大于或等于基线降低4分的患者比例（NRI*计算）

Study Arm

学习手臂

12 weeks

12周

48 weeks

48周

Placebo

安慰剂

30 %

30 %

33 %

33 %

12 μg/kg

12μg/kg

50 %

50 %

22 %

22 %

24 μg/kg

24μg/kg

65 %

70 %

70 %

*NRI: non-responder imputation

*NRI：无应答者插补

Details of the presentations at EADV are as follows:

EADV的演示文稿详情如下：

Efficacy and Safety of Single Agent Rezpegaldesleukin, a Selective Regulatory T-Cell-Inducing Interleukin-2 Conjugate, in the Treatment of Atopic Dermatitis: Final Results from a Randomized Phase 1b Study (Abstract #6685, Session: DT301.3: Late Breaking News. Friday, October 13, 14:30 – 14:45 CET)

选择性调节性T细胞诱导白细胞介素-2偶联物单药Rezpegaldesleukin治疗特应性皮炎的疗效和安全性：随机1b期研究的最终结果（摘要＃6685，会议：DT301.3：最新消息。星期五，10月13日，14:30-14:45 CET）

A Phase 2b, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis (Abstract #6218/ePoster #P0559. Trial in Progress)

一项2b期，随机，双盲，平行组，安慰剂对照研究，以评估Rezpegaldesleukin在成人中度至重度特应性皮炎中的疗效和安全性（摘要＃6218/ePoster＃P0559。正在进行中的试验）

2023 EADV presentations are available for download at http://www.nektar.com/science/scientific-posters.

2023 EADV演示文稿可从以下网址下载：http://www.nektar.com/science/scientific-posters.

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.

自身免疫性和炎性疾病导致免疫系统错误地攻击和破坏人体内的健康细胞。身体自身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可以起到使免疫系统恢复平衡的作用。。

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

REZPEG正在开发为许多自身免疫和炎性疾病的自我给药注射剂。它由Nektar Therapeutics垄断。

About Nektar

关于Nektar

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

Nektar Therapeutics是一家生物制药公司，拥有强大的国有研发免疫学和肿瘤学研究药物管道，以及一系列经批准的合作药物。Nektar总部设在加利福尼亚州旧金山，在阿拉巴马州亨茨维尔设有额外的制造业务。

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功能的更多信息，请访问以下网址：http://www.nektar.com..

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示

This press release contains forward-looking statements which can be identified by words such as: 'will,' 'could,' 'develop,' 'potential,' 'advance,' 'expect,' 'initiate' 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，可以用“意志”，“可以”，“发展”，“潜力”，“前进”，“期望”，“启动”等词语来识别，以及对未来时期的类似引用。前瞻性陈述的例子包括关于rezpegaldesleukin的治疗潜力和未来发展计划的陈述。

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，也不是未来表现的保证。相反，它们仅基于我们目前关于我们业务未来的信念，期望和假设，未来计划和策略，预期事件和趋势，经济和其他未来条件。

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声明中指出的结果大不相同。

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.

因此，你不应该依赖这些前瞻性的陈述。可能导致我们的实际结果与前瞻性陈述中指出的结果有重大差异的重要因素包括：（i）我们关于rezpegaldesleukin治疗潜力的陈述基于临床前和临床发现和观察结果，随着研究和发展的继续而改变；（ii）rezpegaldesleukin是一种研究药物，该候选药物的持续研究和开发存在重大风险，包括未来临床研究中的负面安全性和有效性结果（尽管早期临床前和临床研究中有积极发现）；（iii）rezpegaldesleukin正在临床开发和风险。

Contact:

联系方式：

For Investors:Vivian Wu of Nektar Therapeutics628-895-0661

对于投资者：Nektar Therapeutics的Vivian Wu 628-895-0661

For Media:David Rosen of Argot Partners212-600-1902[email protected]

媒体：Argot合作伙伴David Rosen 212-600-1902[电子邮件保护]

SOURCE Nektar Therapeutics

来源Nektar Therapeutics