KT-621, a potent, selective, oral STAT6 degrader, demonstrated comparable or superior activity to dupilumab in a newly disclosed preclinical chronic asthma model reversing disease progression

KT-621，一种强效、选择性、口服的STAT6降解剂，在新披露的临床前慢性哮喘模型中显示出与dupilumab相当或更优的活性，能够逆转疾病进展。

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

KT-621 第一阶段健康志愿者单次递增剂量/多次递增剂量试验已完成，数据预计于2025年6月公布。

KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) ongoing with data expected in 4Q25

KT-621 BroADen 第一阶段b试验正在进行中，针对中度至重度特应性皮炎（AD），预计数据将在2025年第四季度公布。

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

计划在2025年第四季度和2026年第一季度分别启动针对阿尔茨海默病（AD）和哮喘的两项平行二期b阶段试验。

WATERTOWN, Mass., May 19, 2025 (GLOBE NEWSWIRE) --

马萨诸塞州沃特敦，2025年5月19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 the presentation of additional preclinical data for KT-621, its potent, selective, oral STAT6 degrader and the first STAT6 targeted medicine to enter clinical development.

(NASDAQ: KYMR)，一家处于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口服小分子降解药物，今天宣布了其强效、选择性、口服STAT6降解剂KT-621的更多临床前数据，这是首个进入临床开发的STAT6靶向药物。

The new asthma efficacy mouse model data showed both prevention of disease progression as well as reversal of established disease, building upon the compelling preclinical characterization of KT-621 as a potential once daily, oral treatment for asthma and other Th2 allergic and atopic diseases. These data were presented at the American Thoracic Society (ATS) International Conference being held May 16-21, 2025, in San Francisco, CA..

新的哮喘疗效小鼠模型数据显示，KT-621不仅能够预防疾病进展，还可以逆转已确立的疾病，进一步强化了其作为潜在每日一次口服治疗哮喘及其他Th2过敏性和特应性疾病药物的临床前特性。这些数据于2025年5月16日至21日在加利福尼亚州旧金山举行的美国胸科学会（ATS）国际会议上发布。

Additionally, Jared Gollob, MD, Kymera’s Chief Medical Officer, was featured in an oral showcase presentation as part of the ATS Respiratory Innovation Summit (RIS) discussing the Company’s industry-leading oral immunology portfolio, including the KT-621 program.

此外，Jared Gollob博士，Kymera公司的首席医学官，在ATS呼吸创新峰会（RIS）的一个口头展示报告中亮相，讨论了该公司行业领先的口服免疫学产品组合，包括KT-621项目。

“We believe KT-621 represents an enormous opportunity to expand patient access to an oral systemic advanced therapy in many common immuno-inflammatory diseases, such as asthma, that have limited or suboptimal treatment options,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics.

“我们认为，KT-621 代表着一个巨大的机会，可以扩大患者在许多常见的免疫炎症疾病（如哮喘）中获得口服系统性先进疗法的机会，这些疾病目前的治疗选择有限或不理想，” Kymera Therapeutics 创始人、总裁兼首席执行官 Nello Mainolfi 博士说道。

“KT-621’s impressive and consistent preclinical data package shows the revolutionary potential of STAT6 degradation to phenocopy the activity of upstream biologics, like dupilumab, while offering the convenience of a once daily oral medicine. These encouraging results in an established and clinically validated asthma mouse model with both a prophylactic and now therapeutic treatment regimen further increase our confidence in the transformative potential of KT-621 as we approach our Phase 2b trial in asthma early next year.

“KT-621令人印象深刻且始终如一的临床前数据包展示了STAT6降解革命性的潜力，能够模拟上游生物制剂（如dupilumab）的活性，同时提供每日一次口服药物的便利性。这些在成熟的、临床上已验证的哮喘小鼠模型中取得的鼓舞人心的结果，结合预防性和如今的治疗性给药方案，进一步增强了我们对KT-621转型潜力的信心，因为我们正迈向明年年初的哮喘2b期试验。”

We look forward to sharing updates from our KT-621 Phase 1 trials in healthy volunteers next month and atopic dermatitis patients later this year.”.

我们期待着下个月分享我们KT-621一期试验在健康志愿者中的最新情况，并在今年晚些时候分享特应性皮炎患者的情况。"

The Company previously demonstrated that KT-621 prevents disease progression in the prophylactic intranasal house dust mite (HDM)-induced model in IL-4/IL-4RA humanized mice. KT-621 robustly inhibited all the tested cytokines, chemokines, cell infiltrates, and lung remodeling involved in Th2 inflammation in asthma to an extent comparable or superior to an IL-4Rα saturating dose of the injectable IL-4Rα antibody, dupilumab, included in the same study.

公司此前已证明，KT-621 在 IL-4/IL-4RA 人源化小鼠的预防性鼻内屋尘螨 (HDM) 诱导模型中可防止疾病进展。KT-621 强效抑制了哮喘中 Th2 炎症涉及的所有测试细胞因子、趋化因子、细胞浸润和肺部重塑，其效果与同研究中包含的注射型 IL-4Rα 抗体度匹鲁单抗 (dupilumab) 的 IL-4Rα 饱和剂量相当或更优。

New data shared at ATS show that in the HDM-induced chronic mouse model with a therapeutic treatment regimen, KT-621 administered orally after disease establishment demonstrated comparable or superior activity to dupilumab in blocking Th2 inflammation. The Company also shared new histology data from the therapeutic efficacy model showing amelioration of lung remodeling, including goblet cell metaplasia and MUC5AC mRNA expression, after low daily oral doses of KT-621 that was superior to dupilumab.

在 ATS 上分享的新数据显示，在 HDM 诱导的慢性小鼠模型中采用治疗方案后，KT-621 在疾病建立后口服给药表现出与 dupilumab 相当或更优的 Th2 炎症阻断活性。该公司还分享了来自治疗效果模型的新的组织学数据，显示在每日低剂量口服 KT-621 后，肺部重构（包括杯状细胞化生和 MUC5AC mRNA 表达）得到改善，且效果优于 dupilumab。

Overall, the preclinical data shared to date demonstrate the best-in-pathway potential of KT-621 for the treatment of Th2 allergic and atopic diseases given its dupilumab-like activity profile and the convenience of an oral pill..

总体而言，迄今为止共享的临床前数据表明，鉴于 KT-621 具有类似度普利尤单抗的活性特征以及口服药的便利性，它在治疗 Th2 过敏和特应性疾病方面展现了同类最佳的潜力。

The Company has completed the Phase 1 healthy volunteer trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending (SAD/MAD) doses of KT-621 compared to placebo. In June 2025, Kymera will host a webcast to disclose the complete KT-621 Phase 1 healthy volunteer SAD/MAD data, which will include STAT6 degradation, safety and additional biomarker results.

公司已经完成了第一阶段健康志愿者试验，评估了单次和多次递增剂量（SAD/MAD）的KT-621与安慰剂相比的安全性、耐受性、药代动力学和药效学。2025年6月，Kymera将举行网络直播，披露完整的KT-621第一阶段健康志愿者SAD/MAD数据，其中包括STAT6降解、安全性以及额外的生物标志物结果。

Additionally, the KT-621 BroADen Phase 1b trial in moderate to severe AD patients is ongoing, with data expected to be reported in the fourth quarter of 2025. Two parallel Phase 2b trials in AD and asthma are planned to start in 4Q25 and 1Q26, respectively..

此外，针对中重度AD患者的KT-621 BroADen 1b期试验正在进行中，数据预计将在2025年第四季度报告。两项平行的AD和哮喘2b期试验计划分别于2025年第四季度和2026年第一季度开始。

Copies of both the ATS and RIS presentations are available in the

ATS和RIS演讲的副本均可在

Resource Library

资源库

section of Kymera's website.

Kymera网站的版块。

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 炎症核心驱动因子的特定转录因子。STAT6 降解有可能提供口服药物的便利性，同时具有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，这些患者患有 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。

About Kymera Therapeutics

关于凯米拉治疗公司

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是一家临床阶段的生物技术公司，率先在靶向蛋白质降解（TPD）领域开展工作，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来应对传统疗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已将首款降解剂推进至免疫疾病临床阶段，目前专注于构建行业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Kymera Therapeutics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

或在以下平台关注 Kymera

X (@KymeraTx)

X (@KymeraTx)

and

和

LinkedIn (Kymera Therapeutics

领英 (Kymera Therapeutics)

). 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, press releases, public conference call transcripts and webcast transcripts, 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，包括但不限于企业披露、投资者简报、常见问题解答、证券交易委员会（SEC）文件、新闻稿、公开电话会议记录和网络广播记录，以及 。

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在

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、媒体及其他感兴趣的人士定期查阅 Kymera 在该处发布的信息。Kymera 网站或社交媒体的内容不应被视为在修订后的《1933年证券法》下的任何文件中引用的内容。

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 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 KT-621, including the therapeutic potential, clinical benefits and safety thereof, the advancement in Phase 1 clinical testing.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性陈述，包括但不限于关于我们对战略、业务计划以及KT-621开发进展、时间安排和目标的预期的隐含和明确陈述，包括其治疗潜力、临床益处和安全性，以及在第一阶段临床测试中的进展。

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”、“或许”、“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”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语。

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 successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors.

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，包括但不限于以下相关风险：未来临床试验启动、时间和设计的固有不确定性，正在进行和未来试验的数据可用性及时间安排以及此类试验的结果，临床前结果是否预示临床试验结果，成功证明候选药物安全性和有效性的能力，与监管机构计划互动的时间和结果，满足运营费用和资本支出需求的足够资金的可用性以及其他因素。

These risks and uncertainties are describ.

这些风险和不确定性被描述。

Investor and Media Contact:

投资者和媒体联系：

Justine Koenigsberg

朱斯蒂娜·科尼格斯伯格

Vice President, Investor Relations

投资者关系副总裁

investors@kymeratx.com

投资者@凯默拉公司.com

media@kymeratx.com

媒体@凯美拉科技公司.com

857-285-5300

857-285-5300