Data from the BroADen Phase 1b atopic dermatitis (AD) patient trial expected to be reported in 4Q25

预计将在2025年第四季度报告来自BroADen 1b期特应性皮炎（AD）患者试验的数据。

Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025

已完成KT-621一期健康志愿者试验的SAD/MAD剂量，数据预计于2025年6月公布。

Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively

计划在25年第四季度和26年第一季度分别开始两项针对AD和哮喘的平行二期b阶段试验。

WATERTOWN, Mass., April 22, 2025 (GLOBE NEWSWIRE) --

马萨诸塞州沃特敦，2025年4月22日（环球新闻社）——

Kymera Therapeutics, Inc.

凯米拉治疗公司

(NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that it recently initiated dosing in its BroADen Phase 1b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD).

(NASDAQ: KYMR)，一家临床阶段的生物制药公司，致力于推进一类用于免疫疾病的新型口服小分子降解药物，近日宣布其已启动BroADen 1b期临床试验的给药，该试验评估KT-621（一种口服、高选择性、强效的STAT6降解剂）在中度至重度特应性皮炎（AD）患者中的效果。

The Company expects to report data from the BroADen trial in the fourth quarter of 2025. Additionally, the Company has completed SAD/MAD dosing and follow-up in the KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025..

公司预计将在2025年第四季度报告BroADen试验的数据。此外，公司已经完成了KT-621一期健康志愿者试验的SAD/MAD剂量和随访，数据将于2025年6月报告。

“The advancement of KT-621 in patients with AD is an important step in the development of this exciting program and underscores the potential of our unique technology to revolutionize the treatment of complex immuno-inflammatory diseases through oral medicines with biologics-like profiles,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics.

“KT-621在AD患者中的进展是这一激动人心项目发展的重要一步，突显了我们独特技术通过具有生物制品样特性的口服药物彻底改变复杂免疫炎症疾病治疗的潜力，”Kymera Therapeutics创始人、总裁兼首席执行官Nello Mainolfi博士说道。

“As the first STAT6-targeted agent in clinical development, we believe KT-621 has the opportunity to dramatically alleviate the burden of disease for those suffering from AD by offering an effective and convenient oral medicine, and we look forward to advancing the clinical program and sharing updates throughout the year.”.

“作为临床开发中的首个STAT6靶向药物，我们相信KT-621有望通过提供一种有效且便捷的口服药物，大幅减轻AD患者的疾病负担。我们期待推进临床项目，并在全年分享最新进展。”

The BroADen single-arm, open label Phase 1b trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in approximately 20 adult patients with moderate to severe AD. Patients will be administered KT-621 once daily for 28 days.

BroADen单臂、开放标签的1b期试验将评估口服KT-621在约20名中重度AD成年患者中的安全性、耐受性、药代动力学、药效学和临床活性。患者将每日一次接受KT-621治疗，持续28天。

The key study objective is to show that robust STAT6 degradation in blood and skin by KT-621 has a dupilumab-like effect on reducing multiple Th2 biomarkers in the blood and on the transcriptome of active AD skin lesions. The study will also assess effects on clinical endpoints such as Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS)..

关键研究目标是证明 KT-621 在血液和皮肤中强劲的 STAT6 降解作用对减少血液中的多种 Th2 生物标志物以及活动性特应性皮炎（AD）皮肤病变的转录组具有类似度普利尤单抗的效果。该研究还将评估对临床终点的影响，例如湿疹面积和严重程度指数（EASI）以及瘙痒数字评分量表（NRS）。

Two parallel Phase 2b clinical trials in moderate to severe AD and asthma patients are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Th2 dermatology, gastroenterology and respiratory indications..

预计两项针对中重度AD和哮喘患者的平行二期临床试验将分别于2025年第四季度和2026年第一季度开始。这些研究旨在加速KT-621的开发，并为后续跨多个Th2皮肤科、胃肠病学和呼吸系统适应症的平行三期注册研究选择剂量。

About KT-621

关于KT-621

KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Th2 inflammation. STAT6 degradation has the potential to provide the convenience of an oral medicine with the potential for biologics-like activity and in doing so reach broader patient populations compared to injectable biologics or other standards of care.

KT-621 是一种研究性、首创的、每日一次的口服 STAT6 降解剂，STAT6 是负责 IL-4/IL-13 信号传导和 Th2 炎症核心驱动因素的特异性转录因子。STAT6 降解有可能提供口服药物的便利性，同时具备类似生物制剂的活性，从而相较于注射类生物制剂或其他护理标准能够覆盖更广泛的患者群体。

In preclinical studies, KT-621 demonstrated dupilumab-like activity in several .

在临床前研究中，KT-621 在多个方面表现出类似度普利尤单抗的活性。

in vitro

体外

and

和

in vivo

体内

models and was safe and well tolerated. KT-621, the first STAT6 directed medicine to enter clinical evaluation, has the opportunity to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Th2 diseases such as AD, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others..

模型中表现良好，安全且耐受性佳。KT-621 是首个进入临床评估的针对 STAT6 的药物，有望改变全球超过 1.3 亿患者的治疗模式，包括儿童和成人，他们患有 Th2 类疾病，如特应性皮炎 (AD)、哮喘、慢性阻塞性肺病 (COPD)、伴鼻息肉的慢性鼻窦炎 (CRSwNP)、嗜酸性食管炎 (EoE)、慢性自发性荨麻疹 (CSU) 和结节性瘙痒症 (PN) 等。

More information on the KT-621 BroADen trial in AD will be available on

更多关于KT-621 BroADen试验在AD中的信息将在

www.clinicaltrials.gov

www.clinicaltrials.gov

.

。

About Atopic Dermatitis

关于特应性皮炎

Atopic dermatitis (AD) is the most common form of eczema, a chronic inflammatory disease that causes the skin to become inflamed and irritated, making it extremely pruritic (itchy). AD occurs most frequently in children but also affects adults. It can affect a patient’s quality of life and lead to additional complications, such as infections and sleep loss.

特应性皮炎 (AD) 是湿疹最常见的形式，是一种慢性炎症性疾病，会导致皮肤发炎和受到刺激，使其极度瘙痒。AD 最常发生在儿童中，但也会对成人产生影响。它会影响患者的生活质量，并导致其他并发症，例如感染和睡眠不足。

While there are currently available medicines for AD, such as topical therapies and injectable biologics, there remains a significant unmet need and opportunity to improve treatment options for millions of patients..

尽管目前已有治疗 AD 的药物，如外用疗法和可注射生物制剂，但仍有大量患者存在显著未满足的需求和改善治疗方案的机会。

About Kymera Therapeutics

关于凯米拉治疗学

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics.

Kymera是一家处于临床阶段的生物技术公司，率先在靶向蛋白降解（TPD）领域开展研究，致力于开发解决关键健康问题并有可能显著改善患者生活的药物。Kymera正在利用TPD来应对传统治疗方法无法触及的疾病靶点和通路。

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years.

Kymera已将首个降解剂推进到免疫疾病临床阶段，目前专注于构建业界领先的口服小分子降解剂管线，为这些疾病的患者提供新一代便捷且高效的治疗方案。Kymera成立于2016年，过去几年一直被评为波士顿最佳工作场所之一。

For more information about our science, pipeline and people, please visit .

如需更多关于我们科学、研发管线和人员的信息，请访问。

www.kymeratx.com

www.kymeratx.com

or follow us on

或关注我们

X

X

or

或

LinkedIn

领英

.

。

Availability of Other Information About Kymera Therapeutics

关于凯米拉治疗学的其他信息的可用性

For more information, please visit the Kymera website at

欲了解更多信息，请访问 Kymera 网站：

https://www.kymeratx.com/

https://www.kymeratx.com/

or follow Kymera on

或关注 Kymera 的

X (@KymeraTx)

X (@KymeraTx)

and

和

LinkedIn (Kymera Therapeutics

LinkedIn（凯米拉治疗学）

). Investors and others should note that Kymera communicates with its investors and the public using the Company website, including, but not limited to, corporate disclosures, investor presentations, FAQs, Securities and Exchange Commission (SEC) filings, and press releases, as well as on

). 投资者及其他人士应注意，Kymera通过公司网站与投资者和公众进行沟通，包括但不限于公司披露、投资者演示文稿、常见问题解答、证券交易委员会（SEC）文件和新闻稿，以及在其他平台上发布的信息。

X

X

and

和

LinkedIn

领英

. The information that Kymera posts on its website or on

。Kymera在其网站上发布的信息或

X

X

or

或

LinkedIn

领英

could be deemed to be material information. As a result, the Company encourages investors, the media and others interested to review the information that Kymera posts there on a regular basis. The contents of Kymera’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended..

可能被视为重要信息。因此，公司鼓励投资者、媒体及其他有兴趣的人士定期查阅 Kymera 在该处发布的信息。Kymera 的网站或社交媒体内容不应被视为以引用方式并入依据修订后的《1933年证券法》提交的任何文件中。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示说明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and the progress, timing and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, the advancement of KT-621 in Phase 1 clinical testing, the expectation that two parallel Phase 2b clinical trials are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively and the intention to accelerate KT-621 development for subsequent parallel Phase 3 registration studies.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性声明，包括但不限于关于我们对战略、业务计划以及临床和临床前管线开发进展、时间安排和目标的预期的隐含和明确声明，包括其治疗潜力、临床益处和安全性，KT-621在一期临床测试中的进展，预计两项平行的二期b阶段临床试验将分别于2025年第四季度和2026年第一季度开始，以及加速KT-621开发以进行后续平行三期注册研究的意图。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target,' 'upcoming' and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”、“也许”、“将”、“能够”、“会”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“寻求”、“预测”、“未来”、“项目”、“潜力”、“继续”、“目标”、“即将到来”等词语或类似表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future trials and the results of such trials, whether preclinical results will be indicative of the results of clinical trials, the ability to success.

本新闻稿中的任何前瞻性声明均基于管理层的当前预期和信念，并受多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性声明存在重大差异，包括但不限于：与未来临床试验的启动、时间和设计相关的不确定性、正在进行和未来试验数据的可用性及时间、此类试验的结果、临床前结果是否预示临床试验结果，以及成功能力相关的风险。

Investor and Media Contact:

投资者和媒体联系人：

Justine Koenigsberg

朱斯汀·科尼格斯伯格

Vice President, Investor Relations

投资者关系副总裁

investors@kymeratx.com

投资者@凯默拉_tx.com

media@kymeratx.com

媒体@凯米拉TX.com

857-285-5300

857-285-5300