治疗哮喘和慢阻肺，抗炎单抗获积极临床结果；针对多种实体瘤，靶向放射性疗法获FDA批准进入临床…… | 一周盘点

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药明康德

2026-04-06 07:30发布于江苏药明康德官方账号

问AI · Rademikibart如何实现15分钟内改善患者气道功能？
本期看点：
1. Rademikibart治疗哮喘和慢性阻塞性肺病（COPD）的1期临床试验获积极结果，许多患者在给药后15分钟内气道功能获改善。
2. Aktis Oncology公司宣布，美国FDA已批准其靶向放射性疗法AKY-2519的IND申请，允许其进入1b期临床试验。

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Rademikibart：公布1期临床试验的初步数据


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Connect Biopharma公司公布了其下一代抗白细胞介素-4受体α（IL-4Rα）抗体rademikibart的1期研究的积极顶线结果。Rademikibart是一种靶向IL-4Rα的全人源单克隆抗体，通过阻断IL-4和IL-13的功能来抑制Th2炎症通路，旨在治疗特应性皮炎、哮喘和慢性阻塞性肺病等Th2相关炎症性疾病。


研究数据显示，哮喘和COPD患者在接受单次300 mg、2分钟静脉推注rademikibart后，1秒用力呼气量（FEV1）迅速改善，许多患者在给药后15分钟内FEV1改善≥200 mL。这种快速改善为临床前观察到的rademikibart具有独特的支气管扩张益处提供了临床证实。此外，患者在第29天时仍维持约200-400 mL的平均FEV1改善。该药物总体耐受性良好，未出现严重或重度不良事件，也没有患者因此停药。


AKY-2519：IND申请获得FDA许可


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Aktis Oncology公司宣布，美国FDA已批准其AKY-2519的IND申请，允许其进入1b期临床试验。AKY-2519是一款靶向B7-H3的微型蛋白放射偶联物，旨在将强效的同位素锕-225（actinium-225）选择性地递送至表达该靶点的肿瘤，B7-H3在前列腺癌和肺癌等多种实体瘤中表达。这是Aktis利用其专有平台发现的第二款进入临床阶段的微型蛋白放射偶联物，其主打药物靶向Nectin-4的AKY-1189目前也正在1b期临床研究中招募患者。


ENV-294：公布1b期临床试验数据


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Enveda公司公布了其潜在“first-in-class”、每日一次口服在研疗法ENV-294，在中重度特应性皮炎（AD）患者中进行的1b期临床试验的积极结果。这项开放标签研究纳入了9名曾接受过系统性治疗的成人患者，所有患者均接受了为期28天的每日一次800 mg ENV-294口服给药，随后进行了14天的停药观察。


该研究显示出快速且深度的临床缓解，第42天时湿疹面积和严重程度指数（EASI）平均降低了85%，最早在第8天就观察到了疗效。所有患者（100%）均达到了EASI-50，78%达到EASI-75，56%达到EASI-90，并且在停药后仍有持续改善。在安全性方面，该药物表现出良好的耐受性，未发生严重不良事件，也没有患者因此停药。


PALI-2108：公布1b期临床试验数据


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Palisade Bio公司公布了其在研疗法PALI-2108治疗纤维狭窄型克罗恩病（FSCD）的1b期临床试验的积极顶线数据。PALI-2108是一种PDE4抑制剂前药，能在溃疡性结肠炎和FSCD等疾病部位局部活化，显著提升病变组织内PDE4抑制剂浓度，同时减少全身暴露，从而降低腹泻等传统PDE4抑制剂的不良反应。


该1b期研究在5名患者中取得了令人鼓舞的早期疗效信号。数据显示，患者的克罗恩病简易内镜评分（SES-CD）降低了47.5%，其中40%的患者达到内镜缓解。在安全性方面，该药物在两周的治疗中表现出良好的安全性和耐受性，未发生严重不良事件。此外，药代动力学和药效学数据支持其每日一次的口服给药方案。基于这些积极结果，公司计划将PALI-2108推进至针对中度至重度克罗恩病的2期临床试验。


参考资料：

[1] Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results. Retrieved March 31, 2026, from https://www.globenewswire.com/news-release/2026/03/30/3264994/0/en/Aktis-Oncology-Announces-FDA-Clearance-of-Investigational-New-Drug-Applications-for-AKY-2519-and-Provides-Business-Updates-and-Full-Year-2025-Financial-Results.html

[2] Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy. Retrieved March 31, 2026, from https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-fda-clearance-investigational-new-drug-1

[3] Connect Biopharma Announces Positive Topline Data from its Phase 1 Study of Intravenous (IV) Rademikibart in Patients with Asthma or COPD. Retrieved March 31, 2026, from https://www.globenewswire.com/news-release/2026/03/30/3264480/0/en/Connect-Biopharma-Announces-Positive-Topline-Data-from-its-Phase-1-Study-of-Intravenous-IV-Rademikibart-in-Patients-with-Asthma-or-COPD.html

[4] Palisade Bio Reports Positive PALI-2108 Phase 1b Clinical Data. Retrieved March 31, 2026, from https://palisadebio.com/palisade-bio-reports-positive-topline-data-from-phase-1b-clinical-study-of-pali-2108-in-fibrostenotic-crohns-disease/ 

[5] Bambusa Therapeutics Presented Positive Results from the Phase 1 Multiple Ascending Dose Trial of BBT001 at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-presented-positive-results-from-the-phase-1-multiple-ascending-dose-trial-of-bbt001-at-the-2026-american-academy-of-dermatology-aad-annual-meeting-302731280.html

[6] Enveda Reports Positive Results for ENV-294 in a Phase 1b Clinical Trial of Patients with Moderate-to-Severe Atopic Dermatitis. Retrieved April 2, 2026, from https://www.businesswire.com/news/home/20260331510616/en/Enveda-Reports-Positive-Results-for-ENV-294-in-a-Phase-1b-Clinical-Trial-of-Patients-with-Moderate-to-Severe-Atopic-Dermatitis 

[7] Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/03/31/3265326/28908/en/Tonix-Pharmaceuticals-Announces-Presentation-of-Phase-1-Data-and-Outlines-Planned-Adaptive-Phase-2-Field-Study-of-TNX-4800-for-the-Prevention-of-Lyme-Disease-at-the-World-Vaccine-C.html

[8] Neutrolis Announces Positive First-in-Human Phase 1a Results from LIBERATE-I Trial of NTR-1011, a First-in-Class DNASE1L3 Fusion Protein. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/04/02/3267224/0/en/Neutrolis-Announces-Positive-First-in-Human-Phase-1a-Results-from-LIBERATE-I-Trial-of-NTR-1011-a-First-in-Class-DNASE1L3-Fusion-Protein.html

[9] Alltrna Announces Approval to Initiate First-in-Human Clinical Trial of AP003, the First tRNA Therapeutic to Enter Clinical Trials. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/alltrna-announces-approval-to-initiate-first-in-human-clinical-trial-of-ap003-the-first-trna-therapeutic-to-enter-clinical-trials-302728901.html

[10] Avacta announces first patient treated in Phase 1 FOCUS-01 trial of FAP-Exd (AVA6103) – a sustained-release pre|CISION® exatecan peptide drug conjugate. Retrieved April 2, 2026, from https://avacta.com/avacta-announces-first-patient-treated-in-phase-1-focus-01-trial-of-fap-exd-ava6103-a-sustained-release-precision-exatecan-peptide-drug-conjugate/

[11] Pelthos Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of CT2000 in Eye Pain. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/03/31/3265510/0/en/Pelthos-Therapeutics-Announces-First-Patient-Dosed-in-Phase-1b-2a-Clinical-Trial-of-CT2000-in-Eye-Pain.html

[12] Delonix Bioworks Announces Initiation of Phase 1 First-in-Human Clinical Trial of a Next-Generation MenB OMV Vaccine DX-104. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/delonix-bioworks-announces-initiation-of-phase-1-first-in-human-clinical-trial-of-a-next-generation-menb-omv-vaccine-dx-104-302728529.html

[13] BioLineRx Announces Initiation of Phase 1/2a Study of GLIX1 for the Treatment of Glioblastoma (GBM). Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/biolinerx-announces-initiation-of-phase-12a-study-of-glix1-for-the-treatment-of-glioblastoma-gbm-302725980.html

[14] Adcytherix Doses First Patient in Phase 1 Trial of ADCX-020 and Strengthens Leadership to Support Next Phase of Growth. Retrieved April 2, 2026, from https://www.adcytherix.com/post/adcytherix-doses-first-patient-in-phase-1-trial-of-adcx-020-and-strengthens-leadership-to-support-ne


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