A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

开始日期2023-06-22

申办/合作机构

ACELYRIN, Inc.

NCT05623345

/ Terminated临床2/3期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed for treatment of psoriatic arthritis (PsA).
This study will evaluate the efficacy of izokibep in subjects with PsA.

开始日期2022-11-21

申办/合作机构

ACELYRIN, Inc.

NCT05384249

/ Terminated临床2期

A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

开始日期2022-08-23

申办/合作机构

ACELYRIN, Inc.

100 项与 Izokibep 相关的临床结果

登录后查看更多信息

100 项与 Izokibep 相关的转化医学

登录后查看更多信息

100 项与 Izokibep 相关的专利（医药）

登录后查看更多信息

项与 Izokibep 相关的文献（医药）

2026-03-01·Mediterranean journal of rheumatology

The Pathophysiological Significance of Dual Inhibition of IL-17A and IL-17F in Psoriatic Arthritis and Axial Spondyloarthritis

Review

作者: Lainis, Vasileios ; Vlachoyiannopoulos, Panayiotis G ; Goules, Andreas V ; Katsouli, Olga

Objective:

Spondylarthritides (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are immune-mediated diseases in which the IL-23/IL-17 axis plays a central role. IL-17A inhibition is already a well-established and effective treatment strategy. Emerging evidence suggests that IL-17F, a cytokine closely related to IL-17A but less potent, is not a passive bystander but a key participant in chronic sustained inflammation and therapeutic escape, offering a compelling concept for dual inhibition. This review aims to examine the pathophysiological significance of dual inhibition of IL-17A and IL-17F in psoriatic arthritis and axial spondyloarthritis.

Methods:

Conducting a search through PubMed/MEDLINE, Scopus, and Web of Science, using keywords and Medical Subject Headings (MeSH) terms such as "spondyloarthritis", "psoriatic arthritis", "IL-17A", "IL-17F", "IL-23", "IL-23 independent mechanisms", "dual inhibition", "pathogenesis", "gut-joint axis", "secukinumab", "ixekizumab", "bimekizumab", "sonelokimab", we select the relevant literature for this comprehensive pathophysiological narrative.

Results:

This review examines the distinct and synergistic functions of IL-17A and IL-17F in key tissues, including the synovium, enthesis, skin, gut, and eye, and their contribution to the paradoxical imbalance of bone remodelling. The advent of dual IL-17A/F inhibitors, particularly bimekizumab has revolutionised our therapeutic approach, offering a promising option for patients with difficult-to-treat SpA. We also discuss emerging technology agents, such as sonelokimab and izokibep.

Conclusion:

Inhibiting both IL-17A and IL-17F signifies not only a significant therapeutic advancement but also a vital strategy towards overcoming the limitations of our current armamentarium in achieving deeper and more sustained remission in SpA. Future studies and long-term data will be essential in determining the position of dual IL-17A/F inhibitors within treatment guidelines.

2025-06-01·ANNALS OF THE RHEUMATIC DISEASES

Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study

Article

作者: Wiens, Brian ; Brandt-Juergens, Jan ; Feldwisch, Joachim ; Dokoupilova, Eva ; Drescher, Edit ; Mpofu, Shephard ; Brun, Nikolai C ; Abdel-Kader Martin, Nadia ; Mease, Philip J ; Behrens, Frank ; Ohlman, Sven ; Taylor, Peter C ; Koskinen, Lisa Osterling ; Wetzel, Dieter ; de Vlam, Kurt ; Rowińska-Osuch, Anna ; Stevens, Anne M ; Frejd, Fredrik Y

OBJECTIVES:

To evaluate the efficacy and safety of izokibep, a small protein therapeutic designed to inhibit interleukin-17A, in patients with active psoriatic arthritis (PsA) over 46 weeks.

METHODS:

This phase 2, multicentre, placebo-controlled study randomised adult patients with active PsA 1:1:1 to izokibep 40 mg, izokibep 80 mg, or placebo every 2 weeks for 16 weeks; subsequently, placebo-treated patients switched to izokibep 80 mg. The primary end point was American College of Rheumatology criteria 50 (ACR50) at week 16 for izokibep 80 mg vs placebo. Additional efficacy end points and treatment-emergent adverse events were evaluated through week 16 (placebo-controlled) and week 46.

RESULTS:

Of 172 patients screened, 135 were randomised to izokibep 40 mg (n = 44), izokibep 80 mg (n = 47), or placebo (n = 44). ACR50 response rates were significantly higher for izokibep 80 mg vs placebo at week 16 (52% vs 13%; 2-sided P = .0006) and week 12 (50% vs 6%; P < .0001); lower rates were observed for izokibep 40 mg (48% and 43% for weeks 16 and 12, respectively). Additional analyses of arthritis, psoriasis, enthesitis, dactylitis, and quality of life outcomes supported the efficacy of izokibep at both doses. Response rates generally continued to increase through week 46 with izokibep 80 mg. Treatment-emergent adverse event rates were generally similar across treatment groups except for injection site reactions.

CONCLUSIONS:

Izokibep resulted in significant and clinically meaningful improvements over placebo across multiple disease domains, and the originally randomised 80-mg dose showed continued improvements to week 46. There were no unexpected safety risks identified. Izokibep's small size and high potency have the potential for further improved disease control, justifying additional investigation of higher doses.

2025-06-01·CYTOKINE & GROWTH FACTOR REVIEWS

Interleukin-17: A pleiotropic cytokine implicated in inflammatory, infectious, and malignant disorders

Review

作者: Kurzrock, Razelle ; Lippman, Scott M ; Nishizaki, Daisuke ; Kato, Shumei ; Saran, Anushka

IL-17A, referred to as IL-17, is the founding member of a family of pro-inflammatory cytokines, including IL-17B, IL-17C, IL-17D, IL-17E (or IL-25), and IL-17F, which act via receptors IL-17RA to IL-17RE, and elicit potent cellular responses that impact diverse diseases. IL-17's interactions with various cytokines include forming a heterodimer with IL-17F and being stimulated by IL-23's activation of Th17 cells, which can lead to inflammation and autoimmunity. IL-17 is implicated in infectious diseases and inflammatory disorders such as rheumatoid arthritis and psoriasis, promoting neutrophil recruitment and anti-bacterial immunity, but potentially exacerbating fungal and viral infections, revealing its dual role as protective and pathologic. IL-17 is also involved in various cancers, including breast, colon, cervical, prostate, and skin cancer, contributing to proliferation, immune invasion, and metastases, but also playing a protective role in certain instances. Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies.

173

项与 Izokibep 相关的新闻（医药）

2026-06-28

·自免药研社

中国本土创新药企（不含跨国药企）在自免领域的布局总结

以下整理严格基于公开可查的官方信息、企业公告及 CDE/NMPA 审批进展，按已商业化产品和临床阶段管线两大类别分类呈现，均为中国本土创新药企（不含跨国药企在华子公司）。一、已有商业化自身免疫疾病产品的中国创新药企 1. 恒瑞医药 •夫那奇珠单抗（IL-17A 单抗）：2024 年获批，适应症为中重度斑块状银屑病、强直性脊柱炎 •艾玛昔替尼（高选择性 JAK1 抑制剂）：2025 年获批，适应症覆盖类风湿关节炎、强直性脊柱炎、特应性皮炎、斑秃 •海曲泊帕乙醇胺（TPOR 激动剂）：2021 年获批，适应症包括免疫性血小板减少症（ITP） 2. 荣昌生物 •泰它西普（RC18）（BLyS/APRIL 双靶点融合蛋白）：￮系统性红斑狼疮（SLE）：2021 年附条件获批￮类风湿关节炎（RA）：2024 年获批￮全身型重症肌无力（gMG）：2025 年获批￮IgA 肾病：2025 年获批￮干燥综合征：NDA 阶段 3. 康诺亚生物 •司普奇拜单抗（CM310，商品名：康悦达 ®）（IL-4Rα 单抗）：￮成人中重度特应性皮炎：2024 年 9 月获批￮慢性鼻窦炎伴鼻息肉：2024 年获批￮季节性过敏性鼻炎：2025 年获批￮三项适应症均已纳入国家医保目录 4. 智翔金泰 •赛立奇单抗（GR1501）（IL-17A 单抗）：2024 年获批，适应症为中重度斑块状银屑病 •泰利奇拜单抗（GR1802）（IL-4Rα 单抗）：NDA 阶段，特应性皮炎、季节性过敏性鼻炎 5. 康方生物 •依若奇单抗（AK101）（IL-12/IL-23 p40 单抗）：2025 年获批，适应症为中重度斑块状银屑病，国内首款 IL-12/IL-23 抑制剂 •古莫奇单抗（AK111）（IL-17A 单抗）：NDA 阶段，斑块状银屑病、强直性脊柱炎 •曼多奇单抗（AK120）（IL-4Rα 单抗）：III 期临床完成，特应性皮炎 6. 信达生物 •苏立信 ®（阿达木单抗生物类似药，TNF-α 抑制剂）：已上市，适应症覆盖类风湿关节炎、强直性脊柱炎、银屑病等 •信美悦 ®（匹康奇拜单抗，IBI112）（IL-23p19 单抗）：2025 年 11 月获批，中重度斑块状银屑病，全球首个 PASI 90 突破 80% 的 IL-23p19 抗体 7. 三生国健 •益赛普（重组人 II 型肿瘤坏死因子受体 - 抗体融合蛋白）：国内首个 TNF-α 融合蛋白，已上市多年，覆盖 RA、AS、银屑病等 •安沐奇塔单抗（SSGJ-608）（IL-17A 单抗）：2026 年 2 月获批，中重度斑块状银屑病 8. 百奥泰 •格乐立 ®（阿达木单抗生物类似药）：已上市，国内首个获批的阿达木单抗生物类似药，覆盖 RA、AS、银屑病、克罗恩病等多个自免适应症 •BAT2206（乌司奴单抗生物类似药）：已获 FDA、EMA 批准上市，中国 NDA 审评中 9. 先声药业 •艾得辛 ®（艾拉莫德片）：全球首个获批上市的艾拉莫德药物，活动性类风湿关节炎，2012 年上市 •乐德奇拜单抗（CBP-201）（IL-4Rα 单抗，与康乃德合作）：NDA 阶段，特应性皮炎 10. 荃信生物（与华东医药合作商业化） •赛乐信 ®/ 赛捷宁 ®（乌司奴单抗生物类似药）：2024 年 10 月获批，国内首款乌司奴单抗生物类似药，覆盖斑块状银屑病（成人 + 儿童）、克罗恩病 11. 泽璟制药 •盐酸吉卡昔替尼（曾用名：杰克替尼）（JAK/ACVR1 双抑制剂）：￮中高危骨髓纤维化：2025 年 5 月获批￮成人重度斑秃：2026 年 6 月获批（首个自免领域适应症）￮强直性脊柱炎、特应性皮炎：III 期临床已达终点 12. 君实生物 •阿达木单抗（TNF-α 抑制剂，与迈威生物合作）：已上市，类风湿关节炎等适应症 •偌考奇拜单抗（JS005）（IL-17A 单抗）：NDA 阶段，中重度斑块状银屑病 13. 丽珠集团（丽珠生物） •莱康奇塔单抗（LZM012）（IL-17A/F 双抗）：NDA 阶段，纳入 CDE 优先审评，中重度斑块状银屑病（头对头优效于司库奇尤单抗）二、临床阶段自身免疫疾病研发管线的中国创新药企（一）III 期 / NDA 后期临床阶段 1. 凌科药业 •LNK01001（泽普昔替尼，第二代高选择性 JAK1 抑制剂）：￮特应性皮炎：2026 年 4 月提交 NDA；III 期临床开展中￮类风湿关节炎 III 期：CTR20232969、NCT06276998 ￮强直性脊柱炎 III 期：CTR20233855 ￮白癜风：III 期临床进行中 •LNK01004（外用软性泛 JAK 抑制剂）：特应性皮炎 II 期完成，计划 2027 年启动 III 期 2. 诺诚健华 •索非替尼（ICP-332，TYK2-JH1 抑制剂）：￮特应性皮炎 III 期（已完成入组）：CTR20243202 ￮白癜风：II/III 期临床进行中 •ICP-488（TYK2-JH2 变构抑制剂）：￮银屑病 III 期（已完成入组）：CTR20250582 ￮干燥综合征：II 期临床获批 3. 翰森制药 •HS-10374（TYK2 抑制剂）：银屑病 III 期临床，CTR20243822；EADV 2024 披露 II 期数据优异 •另有 QX004N 等引进管线布局自免领域 4. 正大天晴 •TQH2722（IL-4Rα 单抗）：中重度特应性皮炎 III 期，CTR20242940 •TQC2731（BSI-045B，TSLP 单抗，从博奥信引进）：￮慢性鼻窦炎伴鼻息肉 III 期：CTR20252832 ￮哮喘：II 期临床阶段 5. 创响生物 •IMG-020（izokibep/ABY-035，IL-17A 融合蛋白，从 Affibody 引进）：银屑病、强直性脊柱炎、银屑病关节炎等多个适应症全球 II 期阳性结果，大中华区权益；中国 III 期临床获批 6. 康乃德生物 •CBP-307（S1P1 激动剂）：￮溃疡性结肠炎全球 II 期：NCT04700449 ￮多发性硬化症、克罗恩病：I 期完成即将进入 II 期（二）II 期及早期创新机制阶段 7. 映恩生物 •DB-2304（BDCA2 靶向 ADC，搭载糖皮质激素载荷）：全球首个进入临床的 BDCA2 自免 ADC，I/IIa 期临床，SLE 适应症，澳洲 I 期完成健康受试者给药，美国已启动患者给药 8. 宜明昂科 •IMM0306（阿沐瑞芙普 α，CD47×CD20 双特异性分子）：￮SLE II 期随机对照研究：已完成首例患者入组￮IgG4 相关性疾病 II/III 期：CTR20262001 ￮全球首款进入临床的该靶点双抗自免产品 9. 翎泰天润（LyncBio） •LYNC-101（炎症性肠病 IBD ADC）：全球首个中美双报进入临床的自免 IBD ADC 药物，澳洲 I 期临床进行中 10. 邦耀生物 •BRL-303（异体通用型 CD19 UCAR-T）：难治性 SLE，I 期临床，CTR20260958；全球首款进入 IND 的异体 UCAR-T 自免产品 •BRL-203（非病毒定点整合 CD19 PD1-CAR-T）：难治性 SLE，IND 获批，受理号CXSL2400533 11. 荃信生物（创新双抗管线） •QX027N（TSLP/IL-13 双抗）：国内 I 期临床，IND 受理号CXSL2500757、CXSL2500758；预计 2026 年下半年启动 II 期 •QX030N（IL-23p19/TL1A 双抗）：澳大利亚 I 期临床，首例受试者已入组 •QX031N（TSLP/IL-33 双抗，与罗氏合作）：新西兰 I 期临床，首例受试者已入组 •QX035N（c-kit 双抗）：预计 2026 年下半年提交 IND 12. 信达生物（早期创新管线） •IBI-356（OX40L 单抗）：特应性皮炎 I 期临床，CTR20234129 •IBI-355（CD40L 单抗）：I 期临床，IND 受理号CXSL2300410 •IBI-3002（IL-4Rα/TSLP 双抗）：I 期临床进行中三、重点靶点竞争格局速览靶点类别已上市国产产品数代表企业主要适应症 IL-17A 单抗 5 款 +（含 NDA）恒瑞、智翔金泰、三生国健、康方、君实银屑病、强直性脊柱炎 IL-4Rα 单抗 1 款上市，5 款 + NDA/III 期康诺亚、康方、智翔金泰、先声 / 康乃德、三生国健特应性皮炎、过敏性鼻炎 JAK 抑制剂 2 款上市（艾玛昔替尼、吉卡昔替尼）恒瑞、泽璟、凌科、先声 RA、AS、AD、斑秃 IL-23/IL-12 通路 3 款上市（含生物类似药）康方、信达、荃信 / 华东医药银屑病、克罗恩病 BLyS/APRIL 1 款上市荣昌生物 SLE、RA、重症肌无力 TYK2 抑制剂 0 款上市，3 款 + III 期翰森、诺诚健华银屑病、特应性皮炎自免 ADC/CAR-T 0 款上市，多款 I/II 期映恩、宜明昂科、翎泰天润、邦耀 SLE、IBD 等信息说明：以上整理基于 2026 年 6 月公开可查的企业官网公告、CDE 药物临床试验登记与信息公示平台及权威行业报道。临床管线进展处于动态变化中，部分早期海外临床项目未公开完整登记号，部分临床前项目未纳入。 ⚠️ 免责声明本文档仅为学术研究内容精简总结，仅供医学科研学习、知识参考使用，不构成任何临床诊断、治疗建议或医疗决策依据。 CD38单抗达雷妥尤单-治疗系统性红斑狼疮单臂Ⅱ期临床试验完整总结再闯港股IPO！岸迈生物凭差异化TCE技术，改写自免创新竞争格局突破SLE治疗瓶颈！惠和生物CC312解锁自免TCE一年长效免疫重置新范式艾伯维誓要重塑全球自免药物竞争格局，再次收购 Apogee Therapeutics 跨界突围：Cullinan Therapeutics TCE技术重塑自免治疗格局重磅临床落地定调赛道估值！Cullinan双TCE数据出炉，自免「免疫重置」时代正式落地 2026自免临床重大进展！KT501完成首例RA患者给药，可控型TCE疗法开启精准免疫重置新时代 Kali Therapeutics, Inc：可控型T细胞衔接技术，重塑自身免疫疾病精准治疗赛道从12.3亿美金KT501交易看三特异性TCE价值：自身免疫病下一代治疗技术观察从康诺亚TCE（BCMA_CD3 T细胞衔接器）CM336交易，剖析国产自免创新资产全球化价值兑现全球唯一进入 IgA 肾病临床试验的 BCMA/CD3 T细胞衔接双抗（TCE） 21.75亿美金交易落地！康诺亚CM336：国产TCE技术改写自免免疫重置格局自免新药｜康方生物古莫奇单抗国内正式获批，国产IL-17A单抗再添银屑病治疗新选择康诺亚生物（Keymed Biosciences，2162.HK）：以双抗与TCE重构全球自免格局自免肾病第一大病 IgAN：溯源、病程、靶点与全球新药研发全盘点自免肾病临床缺口凸显：云顶新耀 (1952.HK) 与 Travere (TVTX) 落地 EVER001 全球权益出海合作美上市Biotech Kyverna核心管线miv-cel新数据出炉！KYSA-6 II期临床结果亮眼，重塑重症肌无力治愈新格局美股自免CAR-T龙头官宣CFO上任！一次简单人事任命，给所有Biotech 创新药企敲醒警钟 5月自免新药月报｜全球68款新药换挡！国产2款IL-17单抗同日获批，CAR-T细胞疗法迎来历史性申报节点

2026-06-13

·生物技术小编

还可以抢救一下! Affibody为被弃管线寻找新买家

Izokibep还可以再抢救一下？近日，在EULAR 2026上，Affibody公司口头报告形式公布了Izokibep治疗银屑病关节炎的IIb/III临床Study 22104 52周的数据。试验结果显示：Izokibep展现了持久的疗效和良好的安全性，超过一半患者在52周时达到了ACR50，并且在ACR50/70、PASI90/100及MDA等关键终点上也有一定改善。 Izokibep曾经在Acelyrin公司备受倚重，但因为一项临床失败而迅速导致了这家公司的衰落，再次回到了Affibody的手中。现在，基于在该试验中所观察到的临床表现，Affibody表示了对这条管线未来获得监管批准以及市场前景的高度看好，准备再次为其寻找新的买家。 52周表现 Izokibep是由Affibody公司开发一种IL-17A抑制剂，分子量仅为单抗的十分之一，可通过皮下注射达到传统单抗静脉给药的吸收水平，同时，Izokibep还拥有不输于单抗的半衰期，在皮肤、关节等组织器官领域有着独特治疗优势。此次公布的是一项全球多中心、随机、双盲、安慰剂对照的IIb/III期临床试验结果，共计纳入了343名患者。该试验为期52周，包括16周的安慰剂对照期和36周的活性治疗期。在16周的安慰剂对照阶段，这些患者会先被随机分配至Izokibep（160mg Q2W）、Izokibep（160mg QW）以及安慰剂（QW）组的治疗。在之后的36周活性治疗阶段，Izokibep的两个给药组继续按照原方案，而安慰剂组则是交叉至Izokibep（160mg QW）组。试验主要终点为第16周ACR50应答率（达到50%以上改善的患者比例）。试验结果显示：第52周时，约半数患者达到了ACR50，Izokibep（Q2W）组为50%，Izokibep （QW组）为 57%，安慰剂→Izokibep组为51%。此外，还有相当比例的患者达到了ACR70（36%-42%）、PASI90（63%-69%）、PASI100（55%-64%）和最低疾病活动度（47%-52%）的高门槛终点。安全性方面，试验中未发现新的安全信号，治疗期间不良事件（TEAEs）发生率为81%-88%，其中大多数为轻中度，最常见不良事件为注射部位反应（红斑、瘙痒）和鼻咽炎。命运起落 Izokibep曾以一己之力撑起了一家Biotech公司。 2021年11月，一家名为Acelyrin的初创公司以2500万美元首付款+3亿美元里程碑付款买下了zokibep全球开发和商业化权利（除亚太和北欧部分国家）。而仅仅依靠这一条管线，Acelyrin在成立两年多以来完成了三轮融资，融资总额达到5.58亿美元。在二级市场，其同样是备受追捧。在2023年，Acelyrin以5.4亿美元融资额创下了当时近两年以来生物技术初创公司募资规模最大的一次IPO，可以说是妥妥的资本宠儿。围绕izokibep，Acelyrin也进行了在银屑病关节炎 (PsA) 、化脓性汗腺炎（HS）、葡萄膜炎、中轴型脊柱关节炎 (AxSpA)等多个适应症的临床开发。然而，就在经历了一次临床失败以及甩锅CRO公司事件后，这家公司很快的走向了衰落。 2023年9月，Acelyrin宣布Izokibep治疗化脓性汗腺炎的Ⅱb/Ⅲ期临床未达到主要终点—HiSCR。结果显示：在16周时的HiSCR75（脓肿和炎性结节减少至少75%）评分中，两个Izokibep给药组相比对照组均未达到显著差异。这个临床失败令公司大受打击，Acelyrin股价暴跌了62%。加上之后甩锅CRO公司失败，很快引发了公司一系列动荡，首席执行官辞职、公司裁员重组等。相关阅读：一场甩锅CRO的闹剧后 2024年5月，Acelyrin的创始人兼首席执行官Shao-Lee Lin辞职，新CEO在上任后立即进行了33%的裁员重组。而在这个重组方案中，这条支撑公司一路走来的核心管线被下调了开发优先级，不再是公司最首要、最优先的管线。此外，公司还暂停了对Izokibep银屑病关节炎和化脓性汗腺炎两个适应症上的任何资金投入。 2024年12月，葡萄膜炎IIb/III期试验的失败成为压死izokibep的最后一根稻草，Acelyrin彻底放弃开发。再之后，就是Acelyrin与另一家公司Alumis的合并，而Izokibep这条命途多舛的管线又再次回到Affibody的手中。总结虽然Affibody表现出对Izokibep市场前景十足的看好，但要特别指出的是，作为自身免疫病领域炙手火热的信号通路，Th17靶向药的竞争本就格外激烈，通过头对头PK基本是“一新的IL-17A（F）抑制剂/IL-23抑制剂”确立优势并建立市场地位的必要途径。而Izokibep只是拿出与安慰剂对比数据，其声称的优势在神仙大战的Th17通路领域很难有说服力。参考出处 https://www.fiercebiotech.com/biotech/affibody-gets-izokibep-back-track-while-seeking-new-home-after-acelyrin-rejection https://acrabstracts.org/abstract/efficacy-and-safety-of-izokibep-a-novel-il-17a-inhibitor-in-patients-with-active-psoriatic-arthritis-week-52-results-from-a-randomized-double-blind-placebo-controlled-multicenter-phase-2b-3-stu/ https://www.affibody.se/press/positive-52-week-phase-2b-3-data-of-izokibep-in-psoriatic-arthritis-to-be-presented-at-eular-2026/ 头对头临床第四胜，击败百亿美元大药

临床结果临床2期引进/卖出IPO临床3期

2026-06-05

·FierceBiotech

Affibody gets izokibep ‘back on track’ while seeking ‘new home’ after drug’s Acelyrin rejection

Affibody shared updated data at the EULAR conference in London.\n Affibody may not have expected to be working on izokibep again, but the Swedish biotech hasn’t wasted an opportunity to showcase the inflammation drug’s potential to prospective partners.Stockholm-based Affibody licensed izokibep to California’s Acelyrin for $25 million upfront back in 2021. But the IL-17A inhibitor boomeranged back to Affibody around the time that Acelyrin decided to merge into Alumis last year.“Of course, it was a big surprise,” said Affibody\'s director of corporate development Maria Åkerman, Ph.D., who also serves as project lead for izokibep.Åkerman spoke to Fierce on the sidelines of the European Alliance of Associations for Rheumatology (EULAR) conference in London Wednesday, where Affibody presented data that it claimed showed izokibep’s best-in-class profile across both psoriatic arthritis (PsA) and hidradenitis suppurativa (HS).“Given that we just recently got it back, we are super proud of the data,” she said. “When we\'ve reconnected with the medical field about this, there’s been great enthusiasm.”Izokibep already aced a phase 2b/3 PsA trial under Acelyrin’s guidance back in 2024, when the drug was shown to hit its endpoint of the proportion of patients who saw a 50% or greater improvement in rheumatology symptoms at Week 16.At about one-tenth the size of a monoclonal antibody, izokibep was engineered to reach difficult-to-treat tissues by incorporating an albumin-binding domain that is meant to also improve the therapy’s pharmacokinetic properties. Affibody brought Week 52 data along to EULAR this week to remind people of what the drug can do when compared to PsA mainstays like Novartis’ Cosentyx and UCB’s Bimzelx. Affibody’s slides show izokibep holding its own on measurements like a 50% improvement in rheumatology symptoms (ACR50), as well as a 70% improvement and the proportion of patients who saw a 100% improvement in psoriasis area and severity (PASI100).“ACR50 is sort of the minimal endpoint that you want to reach in order to be successful in this field, but we usually say for izokibep that the higher the bar, the better we are,” Åkerman said.“When you come to the harder-to-reach endpoints—for example, the combination ACR50 and PASI100—people see that there is a field that crystallizes out where you can see what compounds perform the best,” she added. “And we see that izokibep stands out really well.”While Bimzelx and Moonlake Therapeutics’ own arthritis hopeful sonelokimab inhibit both IL-17A and IL-17F, Åkerman is confident in izokibep’s design of only targeting the former. “We know some of the other players in the field emphasize that there is an advantage with targeting IL-17A and F, but we believe our clinical data prove that that\'s not necessarily the case,” she said.Izokibep previously had a slightly tougher time in HS, with Acelyrin reporting back in 2023 that the drug had flunked the second part of a phase 2b/3 study in this inflammatory skin condition. While the trial had failed to hit the mark of a greater than 75% reduction in patients’ abscess and inflammatory nodule count at Week 16, Åkerman said plans for HS are now “back on track.”“There was a clear difference in response between Week 12 and Week 16, and this is known in the field as ‘the HS wobble,’” she said. “So a study can perform extremely well at some time points, but not well in the others.” “The phase 3 data look really, really good,” Åkerman added.Backed by this data, Åkerman said izokibep is only “one study away” from being able to go to regulators. But the plan isn’t for Affibody to see this story through to the end.“We\'re looking for a new home for izokibep,” Åkerman explained. “We could probably pull off a pivotal trial in one of these indications—maybe HS in particular—but the primary goal for Affibody is radiopharmaceuticals, so we\'re more geared towards oncology.”It’s true that although the recently returned izokibep may be the most clinically advanced candidate in the Swedish biotech’s pipeline, the company’s top priority is advancing ABY-271. Affibody is currently dosing the radioligand in the second part of a phase 1 study of patients with HER2-expressing tumors. Another study is penciled in for the second half of next year.Åkerman was unable to share whether Affibody has any buyers lined up for izokibep, but she told Fierce there are ongoing “discussions with several players.”While Affibody may have moved on from izokibep, Åkerman still holds a flame for the inflammation drug.“I would love to go ahead with this [program], but it\'s not my decision,” she said.

临床3期临床1期临床结果上市批准

100 项与 Izokibep 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
化脓性汗腺炎	临床3期	美国	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	日本	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	加拿大	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	法国	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	德国	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	匈牙利	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	波兰	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	西班牙	ACELYRIN, Inc.	2023-06-22
银屑病关节炎	临床3期	美国	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	保加利亚	ACELYRIN, Inc.	2022-11-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05905783 (CTgov)	临床3期	化脓性汗腺炎	258	Placebo+Izokibep (Placebo-Izokibep 160 mg QW)	鏇顧觸醖廠襯艱憲糧鹽(願鑰醖餘鹹鑰鑰餘遞夢) = 窪築願網齋淵艱襯觸鑰齋網鏇襯齋製醖壓衊廠 (窪壓壓鹽網憲觸蓋餘鏇, 範鑰衊衊壓願鏇餘憲窪 ~ 網夢膚願積蓋窪鏇憲顧) 更多	-	2025-10-15
				Izokibep (Izokibep 160 mg QW)	鏇顧觸醖廠襯艱憲糧鹽(願鑰醖餘鹹鑰鑰餘遞夢) = 鑰衊積簾夢鑰淵鬱襯齋齋網鏇襯齋製醖壓衊廠 (窪壓壓鹽網憲觸蓋餘鏇, 齋憲壓糧蓋鹽積築製願 ~ 膚遞築製簾壓鏇壓醖鏇) 更多
NCT05623345 (Study 22104 \| 22104, CTgov)	临床2/3期	银屑病关节炎	351	Placebo (Period 1: Placebo QW)	顧鏇餘網艱積膚膚構餘 = 遞範糧構選獵鑰製製製製襯衊構範繭醖壓獵壓 (襯遞製築鬱範鑰觸壓構, 選衊範遞顧築鬱鬱鏇獵 ~ 觸製鏇餘齋鬱鏇觸衊積) 更多	-	2025-05-23
				Izokibep (Izokibep 80 mg Q4W)	顧鏇餘網艱積膚膚構餘 = 襯築齋糧壓鏇鬱築夢選製襯衊構範繭醖壓獵壓 (襯遞製築鬱範鑰觸壓構, 壓壓鹹醖遞糧製壓窪襯 ~ 鬱蓋蓋膚蓋壓遞糧遞壓) 更多
NCT05623345 (22104, EULAR 12024 \| EULAR 22024) 人工标引	临床2/3期	银屑病关节炎	343	IZO 160 mg Q2W	蓋窪網夢願構觸鏇顧鏇(簾窪膚遞積簾選壓醖鏇) = 鹹糧鏇窪選壓齋鏇構鹹鹹廠廠淵鹽積觸衊鹹獵 (襯醖鑰範鬱蓋鏇製願網 ) 更多	积极	2024-06-12
				IZO 160 mg QW	蓋窪網夢願構觸鏇顧鏇(簾窪膚遞積簾選壓醖鏇) = 艱壓遞衊願壓鬱觸繭鏇鹹廠廠淵鹽積觸衊鹹獵 (襯醖鑰範鬱蓋鏇製願網 ) 更多
NCT05623345 (GlobeNewswire) 人工标引	临床2/3期	银屑病关节炎	351	izokibep	窪顧積簾蓋衊齋願願製(廠範襯壓醖糧選獵願窪) = Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance 壓遞願壓範觸夢齋壓鑰 (範鏇衊壓遞膚簾蓋醖衊 ) 达到更多	积极	2024-03-11
				placebo
NCT05623345 (GlobeNewswire) 人工标引	临床2/3期	化脓性汗腺炎	175	Izokibep 160 mg QW (Part B NRI)	網繭鹹願窪構觸鬱鬱艱(製獵廠窪鏇鑰夢襯齋鏇) = 構範膚艱範繭襯築範齋襯簾鏇網餘顧憲夢顧鬱 (壓製淵顧構積構廠獵壓 ) 更多	不佳	2023-09-11
				Izokibep 160 mg Q2W (Part B NRI)	網繭鹹願窪構觸鬱鬱艱(製獵廠窪鏇鑰夢襯齋鏇) = 齋構製鑰餘糧製積糧醖襯簾鏇網餘顧憲夢顧鬱 (壓製淵顧構積構廠獵壓 ) 更多
EADV2023	临床2/3期	化脓性汗腺炎	-	Izokibep 160mg	蓋獵餘鹹鏇廠選選醖製(網鑰糧積壓糧淵選壓鏇) = 3 SAEs were observed in 2 subjects: inflammatory bowel disease, an exclusionary criterion, in 1 subject with pre-existing symptoms; and peri-colonic abscess/sepsis in another subject with pre-existing symptoms and known diverticulosis 蓋鑰獵夢鏇淵網積鹹壓 (鹽繭餘簾構構鏇鹽鏇築 ) 更多	-	2023-05-18
NCT04713072 (ABY-035-202, PRNewswire) 人工标引	临床2期	银屑病关节炎	-	Izokibep 80 mg Q2W	艱網壓繭範簾遞衊鑰衊(齋餘鏇簾鬱構築簾衊齋) = 鑰醖襯範襯鑰觸築蓋觸願壓壓鏇顧鹽鹹襯窪淵 (構淵築蓋襯齋蓋願廠願 ) 更多	积极	2023-04-11
				Izokibep 40 mg Q2W	艱網壓繭範簾遞衊鑰衊(齋餘鏇簾鬱構築簾衊齋) = 簾蓋鬱鹹選築糧選襯襯願壓壓鏇顧鹽鹹襯窪淵 (構淵築蓋襯齋蓋願廠願 ) 更多
NCT04713072 (ACR2022) 人工标引	临床2期	银屑病关节炎	135	Izokibep 40mg	窪願築蓋獵觸鏇鹽淵淵(糧鬱構觸膚憲願憲顧製) = 襯廠鬱蓋製齋淵鬱構繭築積鏇鹹廠襯蓋鏇憲積 (簾夢觸網餘築齋膚齋鹹 ) 更多	积极	2022-11-13
				Izokibep 80mg	窪願築蓋獵觸鏇鹽淵淵(糧鬱構觸膚憲願憲顧製) = 襯衊膚鬱襯壓壓鏇膚鬱築積鏇鹹廠襯蓋鏇憲積 (簾夢觸網餘築齋膚齋鹹 ) 更多