Rademikibart 是一种靶向 IL-4Rα 的全人源单抗,IL-4Rα 是 IL-4Rα和 IL-13 受体的共同亚基,也是美国 FDA 批准的疗法 (Dupixent®) 的有效靶点。IL-4 和 IL-13具有广泛的重叠功能,是介导多种Th2型炎症性疾病的关键细胞因子。临床前和临床研究数据表明,同时抑制IL-4 和 IL-13对有效控制Th2 型炎症性疾病十分关键。

Rademikibart 与 IL-4Rα 中一个独特的区域结合,阻止后者与其他受体亚基之间的相互作用,进而起到阻断介导Th2 型炎症性疾病(包括特应性皮炎和哮喘)信号通路的作用。

我们的临床开发项目专注于在以下三个方面实现rademikibart的差异化:方便的给药频率、快速起效和临床结果的持续改善。

Rademikibart在以下临床试验中显示出剂量依赖性和差异化的药代动力学和药效学特征:

  • 特应性皮炎的中国关键性临床试验(已完成,顶线结果
  • 哮喘全球2b期临床试验(已完成,顶线结果
  • 特应性皮炎全球2b期临床试验(已完成,顶线结果
开发现状

公司正在考虑将rademikibart推进到3期项目相对于rademikibart的其他开发机会是否是合适的下一步行动。

演讲和出版物

Positive 52-Week Maintenance Data Observed with Rademikibart in Patients with Moderate-to-Severe Atopic Dermatitis (SEASIDE CHINA)
Revolutionizing Atopic Dermatitis (RAD 2024) Conference, June 8-10, 2024

Improved Lung Function and Asthma Control Observed with Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma (CBP-201-WW002)
American Thoracic Society 2024 (ATS 2024), May 17-22, 2024

Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases
Zhang, L., Ding, Y., Wang, Q. et al.;Sci Rep 13, 12411, July 31, 2023

WCD 2023 Primary Poster_19June2023
Presented at the World Congress of Dermatology, July 3-8, 2023

WCD 2023 EASI and Safety Poster_19June2023
Presented at the World Congress of Dermatology, July 3-8, 2023

WCD 2023 Investigator Reported Outcomes Poster_19June2023
Presented at the World Congress of Dermatology, July 3-8, 2023

WCD 2023 Patient Reported Outcomes_19June2023
Presented at the World Congress of Dermatology, July 3-8, 2023

CBP-201 Efficacy by IGA severity_RAD abstract_27March2023
Presented at the;Revolutionizing Atopic Dermatitis (RAD) Conference, April 30, 2023

2023 RAD Poster – CBP-201 Severity – 18Apr2023
Presented at the;Revolutionizing Atopic Dermatitis (RAD) Conference April 30, 2023

CBP-201 CN002 Pivotal_AAD 2023
Presented at the American Academy of Dermatology Annual Meeting, March 17-21, 2023

AAD2023 Late Breaker 11Mar2023
Presented at the American Academy of Dermatology Annual Meeting, March 17-21, 2023

CBP-201 BodyRegion_AAD 2023 Abstract
Presented at the American Academy of Dermatology Annual Meeting, March 17-21, 2023

EASI body region_AAD 2023 Presentation_17Mar2023
Presented at the American Academy of Dermatology Annual Meeting, March 17-21, 2023

CBP-201 investigator rated over time EADV 2022 Abstract
Presented at the 31st European Academy of Dermatology and Venereology Congress (EADV), September 7-10, 2022

Investigator Rated EADV 2022 Poster
Presented at the 31st European Academy of Dermatology and Venereology Congress (EADV), September 7-10, 2022

CBP-201 PRO over time EADV 2022 Abstract
Presented at the 31st European Academy of Dermatology and Venereology Congress (EADV), September 7-10, 2022

PRO-EADV 2022 Poster
Presented at the 31st European Academy of Dermatology and Venereology Congress (EADV), September 7-10, 2022

CBP-201, a novel and differentiated IL-4Rα targeting antibody being evaluated in Th2 inflammatory diseases
SID Annual Meeting, May 18-21, 2022

Efficacy and Safety of CBP-201 in Adults with Moderate-to-Severe Atopic Dermatitis (AD): A Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001)
Presented at the Maui Derm Conference, January 24, 2022

The Effect of Baseline Disease Characteristics on Efficacy Outcomes: Results from a Phase 2b, Randomized, Double-blind, Placebo-controlled Trial of CBP-201 in Adults with Moderate-to-Severe Atopic Dermatitis (AD)
Presented at the Maui Derm Conference, January 24, 2022

Efficacy and Safety of CBP-201 in Adults with Moderate-to-Severe Atopic Dermatitis (AD): A Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001)
Presented at the Maui Derm Conference, January 24, 2022

The Effect of Baseline Disease Characteristics on Efficacy Outcomes: Results from a Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001)
Presented at the Maui Derm Conference, January 24, 2022

1.Weidninger S, Beck LA, Bieber T, et al. Atopic dermatitis. Nature Reviews Disease Primers. 2018;4:1

2.National Eczema Association. Atopic Dermatitis: What is atopic dermatitis? Available at: https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/

3.Asthma and Allergy Association of America. Atopic dermatitis in America: Study overview. Available at: https://www.aafa.org/media/2209/Atopic-Dermatitis-in-America-Study-Overview.pdf

4.2014 Adelphi US AD Disease Specific Programme

5.Holgate ST, Wenzel S, Postma DS, et al. Asthma. Nature Reviews Disease Primers. 2015;1:15025.

关于康乃德生物医药

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