Healthy volunteers phase completed showing differentiating target engagement biomarker data and favorable safety data
有望在2023年获得乳糜泻和嗜酸性粒细胞性食管炎的顶级组织学数据
Proof-of-concept data of CALY-002 in humanized Atopic Dermatitis model supports “pipeline-in-a drug” value proposition
海中女神生物技术, 在开发白介素-15 (IL-15)靶向治疗方面处于领先地位, announces today dosing of the first Eosinophilic Esophagitis patient in the multiple dosing part of the Phase 1 clinical trial of CALY-002, 一种新的人源化和高度分化的单克隆抗体中和IL-15. The ongoing Phase 1 clinical study of CALY-002 includes a single ascending dose (SAD) in Healthy Volunteers as well as multiple ascending dosing (MAD) in cohorts of patients with Celiac Disease or Eosinophilic Esophagitis, 两种具有显著未满足医疗需求的适应症，其中IL-15起关键作用 in their pathogenesis [NCT04593251].
本研究的SAD部分已经完成. 在健康志愿者中广泛的测试剂量水平, CALY-002耐受性良好, 具有IgG单克隆抗体典型的PK谱. 重要的是，目标参与(i.e., IL-15阻断)通过血液中NK细胞数量的减少得到证实, 因为众所周知IL-15是NK细胞的稳态因子. CALY-002是第一个证明人类血液NK细胞减少的il -15特异性抗体, 支撑其独特和差异化的形象.
The MAD part of the study in patients with Celiac Disease or Eosinophilic Esophagitis is currently progressing into the highest dose cohorts. 这个阶段调查安全性, PK, 药理学, disease biomarkers and clinical efficacy endpoints including histology of multiple doses of CALY-002 or placebo over either an 8-week treatment period in a gluten-challenge setting (Celiac Disease) or a 12-week period of open label CALY-002 treatment (Eosinophilic Esophagitis). 两种适应症的顶级组织学数据将在2023年生成.
进一步, CALY-002 was demonstrated to be active in a recently developed humanized model of Atopic Dermatitis, 该研究结果在第51届欧洲皮肤病研究学会(阿姆斯特丹)会议上发表, 2022年9月28日至10月1日). These important data further highlight the potential of CALY-002 in multiple auto-immune indications.
海中女神生物技术公司首席医疗官. Jos Houbiers医学博士评论道 “the demonstrated pharmacological efficacy highlights the potency of CALY-002 and is promising for the clinical histology results in the MAD parts of the study. New and improved treatments are much needed for Celiac Disease and Eosinophilic Esophagitis patients who have limited treatment options. 对于乳糜泻患者, clinical practice learns that adherence to a gluten-free diet is very difficult and many patients continue to experience symptoms; in asymptomatic patients, 小肠的组织学损伤可以不被注意到, 研究显示.’’
关于海中女神生物技术 BV
海中女神生物技术 BV is a private biotechnology company focused on the research and development of novel biologics to address unmet medical need in autoimmune and inflammatory diseases, 在IL-15生物学方面拥有独特的专业知识. IL- 15控制在疾病发生和维持过程中至关重要的免疫通路 (‘’disease memory’’), 以及组织破坏, 除了它对炎症的广泛作用. 海中女神’s approach offers significant advantages over traditional cytokine interventional therapies and could provide for unprecedented long lasting disease-modifying effects in multiple autoimmune diseases. 海中女神生物技术 is a spin-off by the healthcare business of Merck KGaA and is headquartered in Amsterdam, 荷兰, 在日内瓦设有办事处和实验室, 瑞士.