This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)

开始日期2025-11-13

申办/合作机构

MoonLake Immunotherapeutics

CTIS2024-514504-13-00

/ Recruiting临床2期

A Phase 2, open-label, imaging study to explore the effects of sonelokimab in patients with active psoriatic arthritis or axial spondyloarthritis

开始日期2025-09-23

申办/合作机构

MoonLake Immunotherapeutics

NCT07007637

/ Enrolling by invitation临床3期

A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

开始日期2025-06-27

申办/合作机构

MoonLake Immunotherapeutics

100 项与索洛奇单抗相关的临床结果

登录后查看更多信息

100 项与索洛奇单抗相关的转化医学

登录后查看更多信息

100 项与索洛奇单抗相关的专利（医药）

登录后查看更多信息

项与索洛奇单抗相关的文献（医药）

2026-04-01·Function

Tiny tools closing the gap: nanobodies in research and therapy

Review

作者: Leonhardt, Heinrich ; Rajurkar, Jyotirmoy ; Abdellatif, Mustafa

Nanobodies, also known as single-domain antibodies, have become powerful tools in research, diagnosis, and therapy. Sourced from the heavy chain of camelid heavy chain-only antibodies, this domain retains many important characteristics of full-length antibodies while being ∼10 times smaller in molecular weight. Nanobody discovery has seen expansive development over the recent past, through both conventional antigen-exposed and completely synthetic repertoires. Along these lines, binding properties of candidates can be evolved by subsequent mutation and selection cycles to adjust their specificity and avidity. Due to their small size and compact structure, nanobodies can reach cryptic sites not accessible to conventional antibodies and also show superior tissue penetration. This penetrance, alongside their ease of handling, has made nanobodies ideal candidates for a myriad of immunotherapeutic and drug delivery applications. Furthermore, their small size imparts minimal linkage errors when conjugated to a fluorophore, making nanobodies ideal tools for high-resolution imaging techniques. Most importantly, nanobodies can be stably expressed in living cells to bind, block, or modify intracellular targets, enabling study of proteins in a native context at unprecedented detail. In this review, we present the latest developments in nanobody technology and discuss applications in bioimaging, therapy, and intracellular protein study.

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.

2026-02-02·MOLECULAR PHARMACEUTICS

Whole-Body Dynamic PET Imaging of Half-Life Extended Variable Domains of Heavy Chain-Only Antibodies: Beyond Blood Pharmacokinetics

Article

作者: Casteels, Peter ; Hinnen, Françoise ; N’Diaye, Elisa-Racky ; Marchal, Etienne ; Jouannot, Erwan ; Relouzat, Francis ; Goutal, Sébastien ; Richard, Mylène ; Van Bogaert, Tom ; Chevaleyre, Céline ; Lemaitre, Julien ; De Brabandere, Veronique ; Besson, Florent L. ; Kuhnast, Bertrand ; Tournier, Nicolas ; Truillet, Charles

Nanobody molecules are single-domain antibodies derived from stable and fully functional heavy-chain-only (VHH) camelid antibodies. Due to their small size, approximately 15 kDa, their tissue distribution differs from that of conventional antibodies. This study investigates the whole-body pharmacokinetics (WBPK) and specific binding of half-life extended VHHs (HLE-VHHs) using dynamic whole-body immunoPET imaging in nonhuman primates. A HLE-VHH targeting the IL-6 receptor (CD126-VHH) and its nontargeting control (IRR-VHH) were evaluated in vivo after zirconium-89 radiolabeling. We compared microdoses (0.18 ± 0.11 mg/kg, n = 2) and/or pharmacological doses (coinjection, 3.19 ± 0.02 mg/kg, n = 2) of IRR-VHH, alongside microdoses of CD126-VHH (0.25 ± 0.14 mg/kg, n = 2). Initial dynamic whole-body PET scans (240 min) were followed by static PET scans on days 1, 7, and 14. We validated an image-derived input function against the arterial blood sampling method for kinetic modeling. [⁸⁹Zr]IRR-VHHs showed predominantly vascular distribution from day 0 to day 14, with comparable activity patterns and tissue distribution between microdose and pharmacological dose administrations. Early [⁸⁹Zr]CD126-VHH distribution mirrored the nonspecific IRR-VHH pattern, showing strong correlation (R² = 0.87, slope = 1.1) in uptakes of organs, normalized to blood (standard uptake value ratio, SUVR) values at day 0. Interestingly, by days 7 and 14, [⁸⁹Zr]CD126-VHH exhibited higher uptake in bone marrow, spleen, liver, and kidneys, suggesting specific binding. The distribution of [⁸⁹Zr]IRR-VHH in these organs was assumed to reflect the nonspecific uptake of VHHs and was used to estimate the specific binding of [⁸⁹Zr]CD126-VHH. The specific binding of [⁸⁹Zr]CD126-VHH was similarly estimated using either the arterial input function or the image-derived input function (R² = 0.997, p < 0.0001). In plasma, the shorter elimination half-life of [⁸⁹Zr]CD126-VHH (2.0-1.8 days) compared to microdose [⁸⁹Zr]IRR-VHH (5.1-5.0 days) or pharmaco-dose [⁸⁹Zr]IRR-VHH (4.9-4.8 days) suggested target-mediated drug disposition. This study demonstrates the potential of immunoPET for evaluating the target-mediated drug disposition and WBPK of VHH molecules in vivo, providing valuable insights into VHH-based therapeutic strategies.

138

项与索洛奇单抗相关的新闻（医药）

2026-02-25

·科途医学K2Oncology

行业快讯 |医药行业周报：FDA审批范式巨变、全球首款iPS细胞药物获批

行业快讯 NEWS 🏥 医药行业周报 (Generated by AI) 本周摘要：本周医药行业亮点纷呈，核心驱动力体现为以下几个方面：GLP-1/肥胖药物领域的激烈竞争和创新突破，不仅体现在诺和诺德与礼来的头对头较量中，更有腾讯等科技巨头利用AI技术跨界布局，以及辉瑞积极拓展中国市场。再生医学领域迎来里程碑式进展，日本率先批准全球首批iPS细胞衍生药物上市，开启细胞疗法新纪元。M&A和战略合作持续活跃，诺华、吉利德、安斯泰来等巨头通过数十亿美元的交易强化肿瘤、心血管和新兴平台布局。监管政策出现重大调整，美国FDA将单一关键性临床试验作为新药审批的默认标准，旨在加速创新，但其执行一致性仍待观察。同时，AI在药物发现中的作用日益凸显，尤其在多肽和小分子设计中展现出巨大潜力。。🚀 核心重磅 (Top Stories) FDA审批范式变革：单一关键临床试验成新常态美国食品药品监督管理局（FDA）正式宣布，将单一项关键性临床试验作为新药上市申请的默认审批标准，此举标志着新药审批流程自1960年代以来最显著的调整。该政策旨在降低研发成本、加速药物开发，特别对常见病药物的研发周期和成本影响深远。尽管FDA强调将更注重单一试验设计的严谨性和高质量执行，而非简单降低标准，且对癌症和罕见病等领域的影响相对有限（此前已常态化单试验审批），但市场普遍关注该政策对药企研发策略、药物上市速度与安全性平衡、以及长期定价策略的潜在影响。此举有望为资金相对有限的中小型生物科技公司提供更多机遇，但也对单一试验的科学设计和数据可靠性提出了更高要求。再生医学里程碑：全球首批iPS细胞药物在日本获批日本厚生劳动省专家委员会于本周正式批准了两款基于诱导多能干细胞（iPS细胞）技术的再生医疗产品商业化，这是全球范围内首次将iPS细胞技术转化为获批药物，具有划时代的意义。获批产品包括：大阪大学衍生企业Cuorips公司针对严重心力衰竭的“ReHeart”（通过iPS细胞衍生的心肌细胞薄片修复心脏功能）和住友制药与Racthera公司合作开发针对帕金森病的“Amchepry”（通过iPS细胞分化的多巴胺能神经前体细胞补充多巴胺神经元）。这一突破不仅验证了京都大学山中伸弥教授开创性研究的巨大临床价值，更标志着再生医学从基础研究走向临床应用的重大飞跃，为攻克传统手段难以治愈的重大疾病（如心衰和帕金森病）提供了全新范式，并为全球再生医疗产业树立了新的标杆。 M&A热潮持续：聚焦新兴平台与高价值资产：本周全球医药行业M&A和战略合作活动异常活跃，巨头们通过数十亿美元的交易，积极布局创新技术平台和高价值临床资产： 1、吉利德科学以78亿美元（含或有价值权CVR）收购Arcellx，旨在完全控制其核心管线anito-cel（靶向BCMA的CAR-T细胞疗法，用于多发性骨髓瘤），该疗法已获FDA生物制品许可申请（BLA）受理，PDUFA目标日期为2026年12月。此次收购将消除此前的合作分成、里程碑付款和特许权使用费，并进一步利用Arcellx独特的D-Domain CAR技术平台，加速下一代细胞疗法的开发，巩固吉利德在肿瘤学尤其多发性骨髓瘤领域的领先地位。 2、诺华与Unnatural Products（UNP）达成高达17亿美元的合作协议，押注UNP的AI增强型大环肽平台，开发心血管疾病领域的下一代疗法。UNP此前已与默沙东（聚焦肿瘤学）和argenx（探索“不可成药”靶点）达成高额合作，凸显了AI赋能的大环肽技术在解决传统小分子和抗体药物难以触及的“不可成药”靶点方面的巨大潜力。 3、安斯泰来以总价值高达17亿美元的协议与Vir Biotechnology合作开发前列腺癌T细胞接合器（TCE）药物VIR-5500。此举是安斯泰来应对其重磅前列腺癌药物Xtandi专利即将到期的一项重要战略布局。VIR-5500作为一款靶向PSMA和CD3的双特异性TCE，利用Vir的PRO-XTEN双重掩蔽技术，在I期临床中展现出优异的疗效（PSA50/90和ORR数据显著）和良好的安全性（无需预防性类固醇），并实现了每三周一次的便捷给药，有望在竞争激烈的前列腺癌治疗领域占据一席之地。 📈 政策与市场 (Policy & Market) FDA审批政策的复杂性与执行挑战尽管FDA推出单一关键性临床试验作为默认审批标准，旨在提升审批效率，但其在实践中对不同疾病领域和风险程度的药物可能采取差异化策略。例如，近期FDA对Moderna流感疫苗和多款基因疗法仍表现出谨慎态度，要求更多研究数据，这表明“灵活”是有边界的，尤其在疫苗和基因治疗等高敏感领域，审慎原则仍是主导。投资者在解读政策利好时需警惕其执行的一致性和潜在的不确定性。 Bayer巨额和解金以终结Roundup诉讼德国制药巨头拜耳宣布将投入高达72.5亿美元（总计可能超过100亿美元，包括其他历史遗留诉讼）设立赔偿基金，旨在彻底解决收购孟山都带来的Roundup除草剂致癌诉讼的长期困扰。此举被拜耳CEO比尔·安德森形容为“速度与遏制”战略，旨在通过高昂代价换取法律确定性，并寄望于美国最高法院对“联邦优先权”原则的有利裁决，以期从根本上阻断未来基于标签警告的诉讼。尽管拜耳不承认任何责任或不当行为，但市场对此积极反应，拜耳股价上涨，显示投资者对公司摆脱历史包袱、专注于核心业务的期望。。 J&J与Bayer在前列腺癌市场的竞争升级与RWD争议强生因发布一项基于真实世界回顾性分析的新闻稿，声称其前列腺癌药物Erleada在总生存率上比拜耳的Nubeqa有显著优势，遭到拜耳的虚假广告诉讼。这暴露出两大制药巨头在竞争激烈的前列腺癌市场中的白热化竞争。拜耳的指控聚焦于强生RWD方法学上的致命缺陷，包括样本量不平衡、Nubeqa在分析期内超适应症使用导致的患者选择偏倚、以及随访期不足等，强调真实世界数据（RWD）在商业推广中用于声明药物直接优效性时，必须符合严苛的科学严谨性和透明度标准。此案例为行业使用RWD进行营销敲响了警钟。辉瑞加码中国GLP-1市场，拓展代谢疾病版图辉瑞中国与杭州先为达生物达成战略合作，获得先为达新一代偏向型GLP-1受体激动剂埃诺格鲁肽注射液在中国大陆的独家商业化权益。先为达将获得最高达4.95亿美元的付款总额。此举是辉瑞继去年斥资近百亿美元收购Metsera（其核心资产亦为cAMP偏向型GLP-1）后，在全球代谢疾病领域，尤其是在高速增长的中国市场，进一步强化其GLP-1管线布局的重要一步。埃诺格鲁肽已于2026年1月在中国获批治疗2型糖尿病，且其成人长期体重管理适应症的上市申请已被国家药监局受理，展现出强劲的市场潜力。罗氏新药组合NDA受理，聚焦乳腺癌ESR1突变罗氏的在研口服选择性雌激素受体降解剂（SERD）giredestrant与依维莫司联合用药的新药申请（NDA）已获FDA受理，PDUFA审批决定日期定为2026年12月18日。该申请主要针对既往接受过内分泌治疗后复发或进展的雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性且伴有ESR1突变的局部晚期或转移性成人乳腺癌患者。此组合有望成为CDK4/6抑制剂治疗后，首个也是唯一一个获批的口服SERD联合疗法，针对ER阳性乳腺癌的耐药机制提供新的治疗选择。 🧬 研发前沿 (R&D) GLP-1赛道竞争白热化，多维创新并存诺和诺德CagriSema头对头失利：诺和诺德的固定剂量复方制剂CagriSema（cagrilintide+司美格鲁肽）在与礼来替尔泊肽的头对头III期REDEFINE 4试验中未能达到非劣效主要终点。尽管CagriSema自身实现了23.0%的显著体重减轻，但略逊于替尔泊肽的25.5%。这凸显了GLP-1/GIP类药物市场的极度竞争，礼来的双靶点激动剂展现出一定临床优势。诺和诺德仍在积极推进CagriSema的庞大REDEFINE临床开发项目，并计划开发更高剂量版本，以期继续革新肥胖症的护理方案。腾讯跨界AI制药，瞄准GLP-1短肽：腾讯科技申请“GLP1R激活多肽或其药学上可接受的盐及其用途”专利，利用深度生成模型（TPDiffusion、TPBinder）和结构预测技术（AlphaFold）设计出一种全新的短序列GLP1R激活多肽。该多肽旨在克服现有GLP-1类似物序列长、合成复杂、成本高、稳定性差的痛点，并通过体外活性检测验证了其显著的生物活性。这标志着科技巨头深度介入AI药物发现，并直接切入GLP-1这一热门靶点，为药物设计带来新思路。自身免疫疾病治疗新进展，多靶点、联用策略显效：礼来组合疗法开辟新路径：礼来公司的重磅减肥药Zepbound（替尔泊肽，GLP-1/GIP受体激动剂）与自身免疫药物Taltz（依奇珠单抗，IL-17A拮抗剂）的联合疗法，在治疗伴有肥胖或超重的斑块状银屑病（Together-PsO IIIb期）和银屑病关节炎（Together-PsA IIIb期）中均取得显著成功。联合用药在皮肤清除率和体重减轻双重终点上显著优于单药Taltz，表明同时干预代谢和免疫通路，能够有效改善高BMI难治患者的临床预后。这为肥胖相关的慢性炎症疾病（如银屑病、银屑病关节炎）提供了潜在的范式转变，并有望巩固礼来在免疫学市场的竞争优势。赛诺菲/梯瓦TL1A抗体展现长期疗效：赛诺菲与梯瓦合作开发的抗TL1A抗体药物duvakitug在溃疡性结肠炎（UC）和克罗恩病（CD）的2b期长期维持研究中表现出持续且临床意义的疗效，安全性良好。TL1A靶点是炎症性肠病（IBD）领域的热点，其通过阻断TL1A与其受体DR3的结合，从而抑制炎症放大和纤维化驱动过程。尽管duvakitug的开发进度略晚于默沙东和罗氏的同类产品，但其积极数据进一步验证了TL1A作为治疗IBD纤维化和炎症的关键靶点的潜力。 MoonLake IL-17A/F纳米抗体在axSpA中表现积极：MoonLake公司的sonelokimab（SLK，靶向IL-17A和IL-17F的新型纳米抗体）在治疗中轴型脊柱关节炎（axSpA）的II期S-OLARIS试验中取得积极顶线结果，81%的患者在第12周达到了ASAS40缓解标准，并显示深层关节炎症和成骨细胞活性降低。该成功对公司至关重要，因其此前化脓性汗腺炎（HS）项目的III期试验曾因高安慰剂效应而遭受挫折，导致股价暴跌。此次积极数据提升了市场对其核心纳米抗体技术的信心，也预示着该药物在免疫学领域的多重适应症潜力。肿瘤学靶向与免疫疗法持续创新礼来Retevmo在早期肺癌辅助治疗中显效：礼来的高选择性RET激酶抑制剂Retevmo（selpercatinib）在早期（II-IIIA期）RET融合阳性非小细胞肺癌（NSCLC）的III期LIBRETTO-432辅助治疗研究中，显著改善了研究者评估的无事件生存期（EFS），总生存期（OS）亦呈积极趋势。这是该特定人群中首个此类研究的成功，凸显了精准医疗在肺癌早期干预中的巨大价值，并有望推动肺癌患者基因检测的普及。罗氏CLL固定疗程口服组合获批：罗氏的Venclexta（venetoclax，BCL-2抑制剂）与acalabrutinib联合疗法获FDA批准用于既往未接受过治疗的成人慢性淋巴细胞白血病（CLL）患者，提供首个全口服、固定疗程方案。该组合在III期AMPLIFY研究中，相较于化学免疫疗法，显著降低了疾病进展或死亡风险35%，为CLL患者提供了更便利且高效的治疗选择。神经退行性疾病研发面临挑战强生与AC Immune合作开发的靶向Tau蛋白的阿尔茨海默病疫苗（ACI-35.030）二期临床试验因招募挑战而暂停患者招募。尽管并非出于安全隐患，但这一挫折仍反映了阿尔茨海默病研发的复杂性和高风险性，以及生物科技公司在资金和管线管理方面的巨大压力。AC Immune此前已采取裁员和精简管线等措施以延长资金周转期。药物再利用与精准适应症匹配赛诺菲参与Altesa BioSciences的7500万美元B轮融资，以推动曾被视为“失败”的药物vapendavir（抗鼻病毒药物）的2b期临床试验，用于治疗慢性阻塞性肺病（COPD）急性加重。该药物曾因在哮喘试验中未能达到主要终点而受挫，但Altesa团队通过重新配方和精准调整适应症为COPD，成功使其“起死回生”，并在小规模研究中显示出积极疗效。这彰显了药物再利用和精准适应症匹配策略的价值。 |信息说明：本文信息均来源于企业官方公告、监管机构（FDA、EMA、NMPA）发布、权威同行评审期刊、专业财经媒体及中华人民共和国中央人民政府官网，确保内容的准确与客观。 |免责声明：本简报仅作为行业信息参考，不构成任何投资或医疗建议。原创编辑旨在为读者提供更具深度与可读性的行业洞察，版权归本公众号所有。转载请联系授权。欢迎各位咨询——科途官方客服：联系科途医学订购及业务咨询：info@K2Oncology.com 技术服务咨询：TechSupport@k2oncology.com 联系电话：010-67889128，13371633638，17778038351 网址：www.K2Oncology.com 地址： ●北京市北京经济技术开发区经海六路5号院东尚·E园10号楼1层109室 ●浙江省湖州市红丰路1366号6幢10楼1001室 ●河北省廊坊市固安县新兴园肽谷生物医药加速器产业园1号楼A1-1-4室

2026-02-23

·生物制品圈

81% 应答率！IL-17 纳米抗体攻克难治性关节炎

摘要：瑞士生物药企 MoonLake 旗下 IL-17 纳米抗体 sonelokimab，在轴性脊柱关节炎二期临床中交出 81% 的 ASAS40 高应答率答卷，不仅展现出对深层组织的抗炎效果，更让这款曾因临床失利股价暴跌的药物，迎来2026年的关键翻身契机。目前该药物多项三期临床箭在弦上，银屑病关节炎适应症有望年内提交上市申请。二期临床大获全胜，疗效超现有疗法 26 名轴性脊柱关节炎患者，12 周的皮下注射治疗，81% 的患者实现症状至少40%的改善——这是 sonelokimab 交出的二期临床成绩单，直接撞线试验主要终点。要知道，这个被称为 ASAS40 的评估标准，可是当下轴性脊柱关节炎领域获批疗法的核心考核指标，这份数据无疑给临床医生和患者都吃了颗定心丸。参与试验的患者涵盖了强直性脊柱炎这类有明确影像学损伤的重症，也包括仅能通过核磁检测的非放射学类型，基本覆盖了临床常见的患者群体。60mg 的皮下给药剂量，不仅在症状改善上表现亮眼，PET 影像还捕捉到了关键变化：患者骶髂关节的炎症和成骨细胞活性显著降低，要知道这正是关节不可逆钙化的元凶，也是现有疗法难以攻克的痛点。血液和组织的生物标志物分析也印证了疗效，这款药物能快速且持续地掐断驱动炎症和钙化的免疫通路，就像给过度活跃的免疫反应踩下急刹车。纳米抗体独树一帜，直击治疗痛点轴性脊柱关节炎专挑 20 多岁的年轻人下手，胸口、脊柱、骨盆的关节被炎症侵袭，疼、僵、动不了成了患者的日常，全球约 1% 的人受其困扰。目前市面上的疗法不少，阿达木单抗、Skyrizi、Rinvoq 各有千秋，但都有各自的局限。 MoonLake 的底气，来自 sonelokimab 的纳米抗体身份。这款药物完美融合了传统抗体的精准靶向能力，又带着抗体片段的天然优势，生产起来更省心，成本也更可控。更关键的是，它能穿透到关节深层组织发挥作用，这也是现有疗法难以企及的。MoonLake 首席科学官 Kristian Reich 直言，临床、影像、生物标志物的三重数据，印证了这款药物能从根源上控制病情，避免患者走到关节僵硬、失去活动能力的地步，有望改写当下的治疗格局。从暴跌到反弹，2026 成关键翻身年别看如今 sonelokimab 风光无限，去年九月它还让 MoonLake 经历了至暗时刻。彼时这款药物在化脓性汗腺炎的一项三期临床中未达主要终点，即便公司强调整体数据阳性，股价还是应声暴跌近 90%，至今仍未完全回血。好在这次轴性脊柱关节炎的二期大捷，让市场重新看到了希望，周一盘前 MoonLake 股价应声大涨超 9%。而这只是开始，2026 年对这款药物来说堪称关键之年：青少年化脓性汗腺炎的三期临床数据将出炉，银屑病关节炎的两项三期研究也将揭盲，其中银屑病关节炎适应症更是计划在今年下半年提交上市申请。值得一提的是，sonelokimab 并非 MoonLake 原创，2021 年公司从德国默克手中拿下其授权，这款药物最初诞生于赛诺菲旗下的纳米抗体先驱 Ablynx。目前 MoonLake 手握 3.94 亿美元现金，足够支撑到 2027 年下半年，资金层面的充足储备，也为这款药物的临床推进保驾护航。对 MoonLake 而言，sonelokimab 的每一个临床数据，都是一次自我救赎；而对炎症性疾病患者来说，这款能直击深层病灶的纳米抗体，或许真的能带来新的治疗希望。参考来源：https://www.fiercebiotech.com/biotech/moonlakes-phase-2-arthritis-win-kicks-pivotal-year-il-17-nanobody 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

临床2期临床3期申请上市

2026-02-23

·FierceBiotech

MoonLake\'s phase 2 arthritis win kicks off pivotal year for IL-17 nanobody

Yesterday’s axial spondyloarthritis readout is just the latest in a conveyor belt of mid- and late-stage readouts for sonelokimab across a range of inflammatory diseases. \n MoonLake Immunotherapeutics has kicked off a year of readouts for its much-hyped inflammatory disease prospect with a midstage win in a type of arthritis.The Swiss biotech evaluated a 60-mg subcutaneous dose of the IL-17 inhibitor, called sonelokimab, in a phase 2 study of 26 adults with axial spondyloarthritis (axSpA), a chronic inflammatory arthritis. Patients in the study either had the more serious form of radiographic axSpA—also known as ankylosing spondylitis, which is characterized by damage to the sacroiliac joints and can be recognized on X-rays—or non-radiographic axSpA, which is detected by an MRI or another method of clinical investigation. At Week 12, 81% of participants achieved an improvement of at least 40% across a wide-ranging spondyloarthritis measurement—hitting the primary goal of the trial. This Assessment of Spondyloarthritis International Society 40 (ASAS40) measurement has been the primary endpoint for the “latest approved therapies” in the axSpA space, MoonLake noted in its Feb. 22 release.AxSpA typically strikes young adults in their 20s and affects joints in the chest, spine and pelvis. The condition affects roughly 1% of the people in the world, causing significant pain, stiffness and reduced mobility.There are already several drugs approved for axSpA, including AbbVie’s TNF-blocking antibody Humira and JAK inhibitor Rinvoq. With nanobodies like sonelokimab, MoonLake has been hoping to deliver the targeting ability of conventional antibodies with the advantages of an antibody fragment, including easier manufacturing. MoonLake said PET imaging during the phase 2 trial demonstrated “significant reduction of inflammation and osteoblast activity in sacroiliac joints affected by axSpA, a key driver of irreversible ossification in the disease.”Meanwhile, blood and tissue biomarker analyses also showed “rapid and sustained effects of the treatment with SLK in inhibiting key immune pathways known to drive inflammation and ossification in affected patients,” the biotech explained. “The complementary data from clinical outcomes, MRI and PET imaging as well as peripheral blood and tissue biomarkers confirm our hypothesis of sonelokimab\'s ability to access deeper tissue, which is essential to optimally control this chronic rheumatological condition and prevent irreversible mobility restriction,” MoonLake’s founder and chief scientific officer Kristian Reich, M.D., Ph.D., said in a statement. “In our view, the impact of sonelokimab on clinical parameters and key disease pathways observed in S-OLARIS already within the first 12 weeks of treatment highlight the potential of the drug to elevate clinical outcomes and to achieve disease modification in axSpA,” Reich added. “With millions of patients affected by this devastating condition and limited impact of current therapies in improving relevant disease mechanisms, sonelokimab has the potential to change the treatment paradigm in axSpA.”Yesterday’s axSpA readout is just the latest in a conveyor belt of mid- and late-stage readouts for sonelokimab across a range of inflammatory diseases. While most of the data to date have been positive, MoonLake’s share price was shattered last September when the drug missed the key goal of one of a pair of phase 3 studies for its joint-lead indication of severe hidradenitis suppurativa (HS).Despite MoonLake claiming a win across the totality of data for those two HS studies, the company’s stock plunged almost 90% at the time and is yet to fully recover. Still, MoonLake has plenty of opportunities this year to continue to redeem sonelokimab. The rest of 2026 is set to see a flurry of readouts including a phase 3 study of adolescents with HS and two phase 3 readouts in sonelokimab’s other lead indication of psoriatic arthritis.The company is hoping to file an approval application for sonelokimab to treat psoriatic arthritis in the second half of the year, MoonLake affirmed in yesterday’s release. The biotech entered 2026 with $394 million in the bank that it expects to last into the second half of next year. The biotech saw its shares up more than 9% in premarket trading Monday morning. MoonLake licensed sonelokimab from Germany’s Merck KGaA in 2021. The molecule originated at nanobody specialist Ablynx, which is now part of Sanofi.Editor\'s note: This story was updated at 4:45 p.m. ET on Feb. 23 to remove mention of Skyrizi as an approved treatment for axSpA.

$MoonLake\'s phase 2 arthritis win kicks off pivotal year for IL-17 nanobody$

临床2期临床3期临床结果上市批准免疫疗法

100 项与索洛奇单抗相关的药物交易

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
银屑病关节炎	临床3期	美国	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	保加利亚	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	加拿大	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	克罗地亚	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	捷克	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	爱沙尼亚	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	芬兰	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	法国	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	德国	MoonLake Immunotherapeutics	2024-10-15
银屑病关节炎	临床3期	希腊	MoonLake Immunotherapeutics	2024-10-15

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


NCT05640245 (ARGO, ACR2025)	临床2/3期	银屑病关节炎	207	Sonelokimab 60mg WI (Naive to bDMARDs)	積遞餘餘艱鬱窪壓夢製(製齋網築遞構壓願鑰獵) = 遞製夢鬱襯廠積齋壓簾鹹鏇壓餘選淵構遞繭壓 (襯襯簾艱憲膚膚鑰壓積 ) 更多	积极	2025-10-24
				Sonelokimab 60mg NI (Naive to bDMARDs)	積遞餘餘艱鬱窪壓夢製(製齋網築遞構壓願鑰獵) = 廠醖淵築鏇憲襯憲鏇製鹹鏇壓餘選淵構遞繭壓 (襯襯簾艱憲膚膚鑰壓積 ) 更多
NCT05640245 (ARGO, ACR2025)	临床2期	银屑病关节炎	207	Sonelokimab 120mg Q4W with induction (WI)	淵積繭鏇糧襯鏇艱憲襯(廠鏇鬱襯鏇壓鹹觸衊選) = 獵餘艱鏇顧壓鹽網簾窪壓選願鑰顧選餘製遞願 (艱糧壓鏇製憲糧醖製觸 ) 更多	积极	2025-10-24
				Sonelokimab 60mg Q4W with induction (WI)	淵積繭鏇糧襯鏇艱憲襯(廠鏇鬱襯鏇壓鹹觸衊選) = 鹽範夢艱糧鑰糧觸廠襯壓選願鑰顧選餘製遞願 (艱糧壓鏇製憲糧醖製觸 ) 更多
NCT05640245 (ARGO, ACR2025)	临床2期	银屑病关节炎	207	Sonelokimab 60mg NI	鬱蓋觸鹹觸選膚窪鏇遞(鬱構簾醖鹽齋淵壓鹹鹽) = 簾膚鑰廠選獵範繭膚構齋夢糧鬱醖襯蓋蓋餘淵 (範構衊願壓顧憲網構襯 ) 更多	积极	2025-10-24
				Sonelokimab 60mg WI	遞鑰鏇壓蓋艱積襯鏇網(範構築鏇選壓醖觸醖艱) = 衊鑰醖遞鹹蓋襯糧鏇廠顧選遞壓廠鏇鏇淵憲鏇 (範願艱顧積窪蓋構夢獵 ) 更多
NCT06411899 \| NCT06411379 (VELA-2, Company_Website) 人工标引	临床3期	化脓性汗腺炎	838	Placebo (VELA Combined)	醖鑰遞網鹽壓艱憲夢願(顧鹽簾齋顧夢餘蓋製願) = 鹽齋顧鹹壓範鏇觸夢顧淵鹹鏇選廠鬱艱淵積願 (餘蓋鏇網積積窪築蓋襯 ) 更多	积极	2025-09-28
				Sonelokimab 120mg (VELA Combined)	醖鑰遞網鹽壓艱憲夢願(顧鹽簾齋顧夢餘蓋製願) = 蓋艱醖鑰襯憲鹹鬱選築淵鹹鏇選廠鬱艱淵積願 (餘蓋鏇網積積窪築蓋襯 ) 更多
NCT05640245 (ARGO \| M1095-PSA-201, GlobeNewswire) 人工标引	临床2期	银屑病关节炎	207	Sonelokimab	醖糧齋遞膚鏇夢夢鏇鑰(醖艱顧繭鬱構蓋獵襯鹽) = 醖獵鬱淵鹹範獵淵蓋顧廠憲鏇窪廠網窪窪窪膚 (窪觸淵壓襯製鏇壓夢選 ) 更多	积极	2024-03-10
				Placebo	-
NCT05640245 (ARGO \| M1095-PSA-201, Corporate Publications) 人工标引	临床2期	银屑病关节炎	207	Sonelokimab 60mg	衊壓築淵網簾選製衊觸(願積醖遞繭艱廠膚壓齋) = 醖遞蓋鏇鏇糧衊糧蓋醖廠簾獵廠齋窪齋繭糧憲 (製獵廠憲艱繭齋蓋製糧 ) 达到更多	积极	2023-11-05
				Sonelokimab 120mg	衊壓築淵網簾選製衊觸(願積醖遞繭艱廠膚壓齋) = 築鑰觸築醖醖憲艱餘範廠簾獵廠齋窪齋繭糧憲 (製獵廠憲艱繭齋蓋製糧 ) 达到更多
NCT05322473 (MIRA, Biospace) 人工标引	临床2期	化脓性汗腺炎	234	Placebo	鬱廠夢蓋廠糧膚廠鑰壓(鹽齋遞鹽壓餘構選觸鑰) = 範繭襯鹽蓋遞齋壓遞積壓艱淵網膚醖鹽顧鑰壓 (積窪製窪製鏇願齋醖齋 ) 达到更多	积极	2023-10-11
				sonelokimab (120mg)	鬱廠夢蓋廠糧膚廠鑰壓(鹽齋遞鹽壓餘構選觸鑰) = 餘餘鹽襯積衊鬱憲餘蓋壓艱淵網膚醖鹽顧鑰壓 (積窪製窪製鏇願齋醖齋 ) 达到更多
NCT02156466 (CTgov)	临床1期	斑块状银屑病 \| 银屑病 \| 慢性大斑块银屑病	41	MSB0010841 (MSB0010841 30 mg)	製鏇繭憲夢夢構淵廠築 = 遞獵壓憲鏇糧願顧獵齋遞憲鏇鹽淵淵積選積製 (範鹹艱艱遞鏇選製遞襯, 願艱鏇衊願壓築積衊鏇 ~ 膚淵襯構憲衊鏇鹹鏇窪) 更多	-	2017-01-19
				MSB0010841 (MSB0010841 60 mg)	製鏇繭憲夢夢構淵廠築 = 淵簾夢遞顧顧繭壓範選遞憲鏇鹽淵淵積選積製 (範鹹艱艱遞鏇選製遞襯, 襯艱簾夢壓構簾選遞顧 ~ 衊壓夢鬱簾鹹夢觸壓鹽) 更多