莫扎特治疗公司完成健康成人Ph1a期研究；数据显示MTX-101耐受性良好并选择性激活CD8 Treg-动脉网

Mozart Therapeutics Completes Ph1a Study in Healthy Adults; Data Shows MTX-101 is Well Tolerated and Selectively Activates CD8 Treg

CISION 等信源发布 2025-03-17 23:00

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Enrollment of Patients with Autoimmune Disease in Phase

自身免疫性疾病患者在阶段注册

Study has Begun

学习已经开始

SEATTLE

西雅图

，

March 17, 2025

2025年3月17日

/PRNewswire/ -- Mozart Therapeutics, the leading developer of CD8 Treg modulators for the treatment of autoimmune disease, today announce the successful completion of their Phase 1a study of MTX-101 in healthy adults. The randomized, blinded, placebo-controlled study evaluated MTX-101—a first-in-class autoimmune checkpoint inhibitor—as single and multiple doses in an ascending-dose design (.

/PRNewswire/ -- 莫扎特治疗公司（Mozart Therapeutics），作为开发用于治疗自身免疫性疾病的CD8 Treg调节剂的领先企业，今日宣布其针对健康成年人的MTX-101一期1a阶段研究已成功完成。这项随机、双盲、安慰剂对照的研究以单剂量和多剂量递增设计评估了MTX-101——一种首创的自身免疫检查点抑制剂。

NCT06324604

）。

Data from the study in healthy adults show MTX-101 is well tolerated. Most adverse events were low-grade and there were no serious adverse events. Participants receiving MTX-101 experienced transient and self-limited decreases in lymphocytes, which the Company believes are consistent with the study drug's mechanism of action and indicative of target engagement..

健康成人中的研究数据显示，MTX-101 耐受性良好。大多数不良事件为低级别，且无严重不良事件发生。接受 MTX-101 的参与者淋巴细胞出现了短暂且自我限制的减少，公司认为这与研究药物的作用机制一致，并表明靶点已参与作用。

Data further demonstrate that MTX-101 has predictable, dose-dependent pharmacokinetics (PK) and receptor occupancy that are expected to enable a convenient and competitive dosing regimen. Pharmacodynamic data support proof of mechanism and show that MTX-101 is highly selective for regulatory CD8 T cells, and that engagement with MTX-101 results in CD8 Treg activation..

数据进一步证明，MTX-101具有可预测的、剂量依赖性的药代动力学（PK）和受体占用率，预计这将使其能够采用方便且具有竞争力的给药方案。药效学数据支持作用机制的验证，并显示MTX-101对调节性CD8 T细胞具有高度选择性，与MTX-101结合可导致CD8 Treg激活。

Mozart plans to present full data from the Phase 1a study at upcoming medical symposia.

莫扎特计划在即将到来的医学研讨会上公布第一阶段研究的全部数据。

'We are thrilled that the initial MTX-101 Phase 1 data in healthy adults confirm the mechanistic and safety findings from our pre- and nonclinical studies. This represents not only an important milestone for Mozart, but also a significant achievement as we work to advance a class of CD8 Treg modulators to restore durable immune homeostasis in autoimmune disease,' said .

“我们感到非常兴奋，MTX-101一期试验的初步数据在健康成年人中验证了我们临床前和非临床研究的机制与安全性结果。这不仅代表了莫扎特公司的一个重要里程碑，也标志着我们在推进一类CD8 Treg调节剂以恢复自身免疫疾病中的持久免疫稳态方面取得了显著成就，”该公司表示。

Katie Fanning

凯蒂·范宁

, President and Chief Executive Officer of Mozart Therapeutics.

，莫扎特治疗公司的总裁兼首席执行官。

'Our observations from the healthy adults hold great promise for patients with autoimmune disease,' echoed

“我们从健康成年人身上得到的观察结果，对自身免疫性疾病患者来说也充满希望，”他补充道。

Jason Chien

钱杰森

, M.D., M.S., Mozart's Chief Medical Officer. 'The well-tolerated safety profile, antibody-like PK, and clear evidence of target engagement and activation represent an exciting novel class of therapeutics that has the potential to deliver substantial clinical benefit. With these data, we are quickly advancing MTX-101 in patients with type 1 diabetes and celiac disease.'.

，医学博士，理学硕士，莫扎特公司的首席医学官。“其良好的安全性特征、类似抗体的药代动力学特性以及明确的靶点参与和激活证据，代表了一类令人兴奋的新型治疗药物，有可能带来显著的临床益处。基于这些数据，我们正在快速推进MTX-101在1型糖尿病和乳糜泻患者中的应用。”

The first patients with type 1 diabetes and celiac disease have been enrolled in Part B of the study, which is being conducted at multiple clinical sites in

第一部分B型糖尿病和乳糜泻的首批患者已在多个临床站点注册参加研究，

Australia

澳大利亚

. 'MTX–101 has a novel mechanism of action that has great potential to improve the lives of people living with autoimmune disease,' said Professor

“MTX-101具有一个全新的作用机制，有极大的潜力改善自身免疫疾病患者的生活，”教授表示。

John Wentworth

约翰·温特沃斯

, M.D.; Endocrinologist, The Royal Melbourne Hospital Department of Medicine; Senior Clinical Research Fellow, St Vincent's Institute of Medical Research; Director,

，医学博士；内分泌学家，皇家墨尔本医院内科部门；高级临床研究员，圣文森特医学研究所；主任，

ANZ Type

ANZ类型

1 Diabetes TrialNet. 'This is why our type 1 diabetes community is so excited to participate in the MTX-101 development program and help determine its ability to decrease dependance on insulin injections.'

1型糖尿病试验网（Diabetes TrialNet）表示：“这就是为什么我们的1型糖尿病社区对参与MTX-101开发计划感到如此兴奋，并帮助确定其减少对胰岛素注射依赖的能力。”

About MTX-101

关于MTX-101

MTX-101 is an antigen-agnostic bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of CD8 Treg, acting early in the autoimmune disease process to suppress and eliminate pathogenic T cells, halt downstream inflammation, and prevent tissue destruction..

MTX-101是一种抗原不可知的双特异性抗体，靶向抑制性KIR和表达在调节性CD8 T细胞上的CD8。这种自身免疫检查点抑制剂旨在恢复CD8 Treg的内在功能，在自身免疫疾病过程的早期发挥作用，以抑制和消除致病性T细胞，阻止下游炎症，并防止组织破坏。

About Mozart Therapeutics

关于莫扎特治疗公司

Mozart Therapeutics is focused on developing first-in-class disease-modifying therapies for autoimmune diseases, utilizing a novel approach to restoring immune system function by targeting the CD8 T regulatory network. The company is headquartered in

Mozart Therapeutics 专注于为自身免疫性疾病开发首创的疾病修饰疗法，利用一种新方法来恢复免疫系统功能，靶向 CD8 T 调节网络。公司总部位于

Seattle, WA.

华盛顿州西雅图市。

For more information, visit

欲了解更多信息，请访问

www.mozart-tx.com

and follow the company on LinkedIn

关注公司在LinkedIn上的动态

@Mozart–tx.com

@莫扎特–德克萨斯.com

。

SOURCE Mozart Therapeutics