Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12

顶线结果还显示，研究性靶向口服肽icotrokinra在第12周时达到了高达30.2%的临床缓解率。

and a favorable safety profile

并且具有良好的安全性

in Phase 2b ANTHEM-UC study

在2b期ANTHEM-UC研究中

Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program

临床反应和缓解率持续改善至第28周，基于最近报道的斑块型银屑病三期项目数据。

Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment

Icotrokinra展示出每日一次口服治疗的潜在疗效和耐受性。

SPRING HOUSE, Pa.

宾夕法尼亚州斯普林豪斯

,

，

March 10, 2025

2025年3月10日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了ANTHEM-UC 2b期研究的积极顶线结果。该研究涉及icotrokinra（JNJ-2113），这是一种首个在研的靶向口服肽，可选择性阻断IL-23受体，用于治疗中度至重度活动性溃疡性结肠炎（UC）的成人患者。

The study met its primary endpoint of clinical response.

该研究达到了其临床反应的主要终点。

a

a

in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission

在所有评估的伊科曲金剂量组中，与安慰剂相比，在临床缓解的关键次要终点上显示出有临床意义的差异。

b

b

, symptomatic remission and endoscopic improvement at Week 12.

，第12周时症状缓解和内镜改善。

In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo (p<0.001). Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001).

在 ANTHEM-UC 研究（n=252）中，测试了每日一次的三种剂量的 icotrokinra，所有剂量均在第 12 周达到了临床反应的主要终点。接受最高剂量 icotrokinra 治疗的患者在第 12 周的反应率为 63.5%，而安慰剂组为 27%（p<0.001）。此外，接受最高剂量 icotrokinra 治疗的患者中有 30.2% 在第 12 周达到临床缓解，而接受安慰剂的患者为 11.1%（p<0.001）。

Remission and response rates continued to improve through Week 28..

第28周时，缓解率和应答率持续提高。

1

1

Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.

Icotrokinra 耐受性良好，报告一个或多个不良事件（AEs）的参与者比例在icotrokinra剂量组和安慰剂组之间相似。

1

1

'These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment,' said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson.

“这些令人印象深刻的研究结果表明，icotrokinra 有潜力通过每日一次口服治疗的独特组合，为溃疡性结肠炎患者带来疗效、耐受性和便利性的全面提升，从而改变治疗模式。” 强生公司免疫学胃肠病领域副总裁 Esi Lamousé-Smith 医学博士表示。

'With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.'.

“凭借我们在炎症性肠病领域超过四分之一世纪的创新，以及在IL-23通路方面的深厚专业知识，我们对这些结果感到兴奋，并对icotrokinra在治疗免疫介导疾病方面的突破性潜力充满期待。”

Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses.

ANTHEM-UC研究的综合结果正在准备中，将在即将召开的医学大会上展示。

Editor's notes:

编辑注释：

a. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

临床反应定义为改良Mayo评分较基线减少大于或等于30%且减少至少2分，同时直肠出血子评分较基线减少至少1分或直肠出血子评分为0或1。

b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.

b. 临床缓解定义为Mayo大便频率子评分为0或1且未较诱导基线增加，Mayo直肠出血子评分为0，以及Mayo内镜子评分为0或1且内镜检查无脆性表现。

About ANTHEM-UC

关于ANTHEM-UC

ANTHEM-UC (

国歌-UC (

NCT06049017

NCT06049017

) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally..

）是一项二期多中心、随机、安慰剂对照、剂量范围研究，旨在评估icotrokinra（JNJ-77242113，JNJ-2113）在中度至重度活动性溃疡性结肠炎患者中的疗效和安全性，这些患者对传统疗法（如硫嘌呤或皮质类固醇）、先前的生物制剂（TNF拮抗剂或维多珠单抗）和/或奥扎尼莫德或已批准的JAK抑制剂反应不足或不耐受。该研究正在评估三种每日一次口服的icotrokinra剂量。

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2

About Ulcerative Colitis

关于溃疡性结肠炎

Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue..

溃疡性结肠炎（UC）是一种大肠（也称为结肠）的慢性疾病，其中结肠内壁发生炎症，并形成微小的开放性溃疡，这些溃疡会产生脓液和粘液。这是免疫系统过度反应的结果。症状各有不同，但通常可能包括大便稀疏且更紧迫、直肠出血或血便、持续腹泻、腹痛、食欲不振、体重减轻和疲劳。

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3

About Icotrokinra (JNJ-77242113, JNJ-2113)

关于Icotrokinra（JNJ-77242113，JNJ-2113）

Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,

研究性药物icotrokinra是首个设计用于选择性阻断IL-23受体的靶向口服肽，

4

4

which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.

这支撑了中度至重度斑块型银屑病和溃疡性结肠炎中的炎症反应，并为其他IL-23介导的疾病提供了潜在可能。

5,6

5,6

Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells.

Icotrokinra以个位数皮摩尔的亲和力结合IL-23受体，并在人类T细胞中显示出对IL-23信号传导的有效且选择性的抑制作用。

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7

The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.

2017年，Protagonist Therapeutics公司与强生旗下的Janssen Biotech公司达成的许可与合作协议，使双方能够共同合作发现和开发下一代化合物，最终促成了icotrokinra的诞生。

8

8

Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications..

Icotrokinra 是由 Protagonist 和强生公司根据许可和合作协议共同发现并正在开发的。强生公司保留在 II 期临床试验及以后阶段开发 icotrokinra 的全球独家权利，并有权将依据该协议进行的研究中产生的化合物针对广泛适应症进行商业化。

9,10,11

9，10，11

Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis.

Icotrokinra 正在关键的 III 期 ICONIC 临床开发项目中进行研究，用于中至重度斑块型银屑病和活动性银屑病关节炎，并在 IIb 期 ANTHEM-UC 研究中针对中至重度活动性溃疡性结肠炎进行研究。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity..

在强生，我们相信健康就是一切。我们在医疗保健创新方面的实力使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们具备独特的优势，能够在当今整个医疗保健解决方案领域进行创新，提供明日的突破性成果，并对人类健康产生深远影响。

Learn more at

了解更多请访问

https://www.jnj.com/

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

www.innovativemedicine.jnj.com

.

。

Follow us at

关注我们

@JNJInnovMed.

@JNJInnovMed

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

扬森研发有限责任公司和扬森生物科技公司是强生公司的子公司。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc.

本新闻稿包含根据1995年《私人证券诉讼改革法案》定义的关于icotrokinra（JNJ-2113）的“前瞻性声明”。读者请注意，不要过分依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确或已知或未知的风险或不确定性成为现实，实际结果可能与杨森研发有限责任公司和杨森生物科技公司的预期和预测大相径庭。

and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

和/或强生公司。风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；对专利的挑战；产品功效或安全性问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述可以在强生公司最近的年度报告 Form 10-K 中找到，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件中。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

www.sec.gov

,

，

www.jnj.com

www.jnj.com

or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

或应强生公司的要求。杨森研发有限责任公司、杨森生物科技公司及强生公司均不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任。

1

1

Data on file.

数据存档。

2

2

Clinicaltrials.gov

临床试验.gov

. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017.

. 研究JNJ-77242113在中度至重度活动性溃疡性结肠炎（ANTHEM-UC）参与者中的应用。标识符：NCT06049017。

https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1

https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1

.  Accessed February 2025.

访问时间：2025年2月。

3

3

Crohn's & Colitis Foundation. What is ulcerative colitis? Available at:

克罗恩病和结肠炎基金会。什么是溃疡性结肠炎？可用资源：

https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis

https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis

. Accessed April 2024.

访问时间：2024年4月。

4

4

Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.

比松内特 R 等。数据展示。一项二期、随机、安慰剂对照、剂量范围研究，评估口服 JNJ-77242113 治疗中至重度斑块型银屑病的效果：FRONTIER 1。在 2023 年世界皮肤病学大会（WCD）上发表，时间为 7 月 3 日至 8 日。

5

5

Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling.

Razawy W, 等。IL‐23受体信号在炎症介导的侵蚀性自身免疫性关节炎和骨重塑中的作用。

Eur J Immunol

欧洲免疫学杂志

. 2018 Feb; 48(2): 220–229.

. 2018年2月；48（2）：220-229。

6

6

Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases.

唐 C 等。白细胞介素-23：作为自身免疫性炎症疾病的药物靶点。

Immunology

免疫学

. 2012 Feb; 135(2): 112–124.

. 2012年2月；135（2）：112-124。

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7

Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.

Pinter A等人。数据展示。JNJ-77242113治疗在斑块型银屑病患者的血清样本中相较于安慰剂诱导了强烈的全身药效学反应：来自2期FRONTIER 1研究的结果。在2023年EADV大会（10月11日至14日）上发表。

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8

Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at:

强生公司新闻发布。杨森与Protagonist Therapeutics, Inc.达成全球独家许可和合作协议，针对口服白细胞介素-23受体拮抗剂候选药物，用于治疗炎症性肠病。获取地址：

https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease

https://www.jnj.com/media-center/press-releases/杨森与Protagonist Therapeutics达成全球独家许可及合作协议，针对炎症性肠病治疗的口服白细胞介素-23受体拮抗剂候选药物

. Accessed November 2024.

. 2024年11月访问。

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9

Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at:

Protagonist Therapeutics. 新闻稿。Protagonist Therapeutics 宣布与 Janssen Biotech 修改协议，继续开发和商业化 IL-23 拮抗剂。可用链接：

https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html

https://www.prnewswire.com/news-releases/主角治疗公司宣布与詹森生物技术公司修订协议以继续开发和商业化IL-23拮抗剂-301343621.html

. Accessed November 2024.

访问于2024年11月。

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Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at:

Protagonist Therapeutics发布新闻稿。Protagonist报告了口服白细胞介素-23受体拮抗剂JNJ-2113的1期和临床前研究的积极结果。可用链接：

https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html

https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html

. Accessed November 2024.

访问时间：2024年11月。

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Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at:

主角治疗公司。新闻稿。主角治疗公司宣布口服IL-23受体拮抗剂JNJ-2113（PN-235）在银屑病的2b期FRONTIER 1临床试验中取得积极的初步结果。可用链接：

https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html

https://www.prnewswire.com/news-releases/主角治疗公司宣布口服IL-23受体拮抗剂JNJ-2113-PN-235在银屑病2b期前沿1临床试验中取得积极的初步结果-301764181.html

. Accessed November 2024.

。访问于2024年11月。

Media contact:

媒体联系人：

Craig Stoltz

克雷格·斯托尔茨

cstoltz@its.jnj.com

cstoltz@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients-302396524.html

https://www.prnewswire.com/news-releases/icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients-302396524.html

SOURCE Johnson & Johnson

来源：强生公司