Evommune启动了MRGPRX2拮抗剂EVO756在中重度慢性自发性荨麻疹成人患者中的2b期试验-动脉网

Evommune Initiates Phase 2b Trial of MRGPRX2 Antagonist, EVO756, in Adults with Moderate to Severe Chronic Spontaneous Urticaria

CISION 等信源发布 2025-04-15 21:00

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Novel mechanism of action (MOA) inhibits MRGPRX2 on both mast cells and peripheral sensory neurons - a key differentiator to other therapeutic options

新型作用机制（MOA）抑制肥大细胞和外周感觉神经元上的MRGPRX2——这是与其他治疗选择的关键区别。

Potential first- and best-in-class safety and efficacy profile for patients suffering from a broad range of chronic inflammatory diseases

潜在的首创和最佳安全性和有效性，适用于患有多种慢性炎症疾病的患者。

Global Phase

全局阶段

trial is Phase 3 enabling, with data expected in mid-2026

试验处于启用第3阶段，预计2026年年中获得数据。

PALO ALTO, Calif.

加利福尼亚州帕洛阿尔托

，

April 15, 2025

2025年4月15日

/PRNewswire/ -- Evommune, Inc., a clinical stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced the enrollment of the first patient in a global Phase

/PRNewswire/ -- Evommune, Inc.是一家临床阶段的生物技术公司，致力于发现和开发治疗免疫介导的炎症性疾病的新方法，今天宣布了其全球第三阶段试验中第一名患者的入组。

trial of EVO756, an orally available, highly potent and selective small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2), in adults with moderate to severe chronic spontaneous urticaria (CSU).

EVO756 的试验，这是一种口服的、高效且选择性的小分子拮抗剂，针对 mas 相关 G 蛋白偶联受体 X2 (MRGPRX2)，用于治疗中度至重度慢性自发性荨麻疹 (CSU) 的成人患者。

'The dual mechanism of EVO756, which has been shown in preclinical studies to address MRGPRX2 activation on both mast cells and peripheral sensory neurons, represents a promising new therapeutic approach for CSU and a broad range of other inflammatory diseases for which new treatments are urgently needed.

EVO756的双重机制在临床前研究中已被证明能够应对肥大细胞和外周感觉神经元上的MRGPRX2激活，这代表了一种针对CSU和一系列其他炎症性疾病的有前景的全新治疗策略，而这些疾病迫切需要新的治疗方法。

Building upon these studies and our previously disclosed EVO756 clinical proof-of-concept data, we are pleased to have the Phase .

基于这些研究和我们之前披露的EVO756临床概念验证数据，我们很高兴进入第阶段。

CSU trial now underway. In addition, we are planning to initiate a separate Phase

CSU试验现在正在进行中。此外，我们计划启动一个单独的第三阶段试验。

trial of EVO756, in atopic dermatitis, later this year,' said Luis Peña, President and CEO at Evommune.

Evommune公司总裁兼首席执行官路易斯·佩尼亚表示：“EVO756在特应性皮炎中的试验将于今年晚些时候进行。”

'Enrollment of our open-label Phase 2 chronic inducible urticaria trial is nearly complete, and we believe the pharmacokinetic, pharmacodynamic, and safety data generated on EVO756 warrant the initiation of our Phase

“我们开放标签的二期慢性诱导性荨麻疹试验的入组工作已接近完成，我们认为关于EVO756生成的药代动力学、药效学和安全性数据支持启动我们的三期

trial and we look forward to reporting the CSU data in 2026,' said Eugene Bauer, M.D., Chief Medical Officer at Evommune.

试验，我们期待在2026年报告CSU数据，”Evommune首席医学官Eugene Bauer博士表示。

EVO756 is being evaluated in a global, multi-center, Phase

EVO756正在全球、多中心、第三阶段进行评估。

randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety in adults with moderate to severe CSU. Approximately 160 patients will be enrolled and patients will be randomized to receive one of three active dose regimens or placebo.

随机、双盲、安慰剂对照、剂量范围研究，评估成人中重度CSU的疗效和安全性。大约160名患者将被纳入研究，并随机接受三种活性剂量方案之一或安慰剂。

About Chronic Spontaneous Urticaria (CSU)

关于慢性自发性荨麻疹（CSU）

Chronic spontaneous urticaria (CSU) is the name for hives (urticaria) that are chronic, lasting six or more weeks, three to four times per week, and have no known cause (spontaneous). One in five people will get hives at some time during their life. The activation of the mast cells in the skin (release of histamines, leukotrienes, chemokines) results in episodes of itchy hives, swelling, and inflammation of the skin that can persist for years or even decades.

慢性自发性荨麻疹（CSU）是指持续六周或更长时间、每周发作三到四次、且原因不明（自发性）的荨麻疹。五分之一的人在生命中的某个阶段会出现荨麻疹。皮肤中肥大细胞的激活（释放组胺、白三烯、趋化因子）会导致瘙痒性荨麻疹、肿胀和皮肤炎症的反复发作，这种状况可能持续数年甚至数十年。

CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options..

CSU 通常使用 H1 抗组胺药进行治疗，这类药物通过作用于细胞上的 H1 受体来控制荨麻疹的症状。然而，许多患者即使在接受抗组胺药治疗后，病情仍然无法得到控制，其中一些患者的替代治疗选择非常有限。

About MRGPRX2 and EVO756

关于MRGPRX2和EVO756

MRGPRX2, is a G-Protein-Coupled-Receptor (GPCR) found on mast cells (MC) and sensory neurons. It facilitates potent degranulation in MCs, and on sensory neurons, driving neurogenic inflammation and sensations such as cough, pain, and itch. The receptor is activated by a broad spectrum of ligands that are prevalent during inflammation.

MRGPRX2是一种在肥大细胞（MC）和感觉神经元上发现的G蛋白偶联受体（GPCR）。它能够促使肥大细胞发生强烈的脱颗粒反应，并在感觉神经元上引发神经源性炎症以及咳嗽、疼痛和瘙痒等感觉。该受体可被炎症期间普遍存在的多种配体激活。

Targeting MRGPRX2 may have potential across an array of MC-mediated diseases and in mitigating neurogenic inflammation..

靶向MRGPRX2可能在多种MC介导的疾病和减轻神经源性炎症方面具有潜力。

EVO756 is a small molecule antagonist of MRGPRX2 that is being developed as a first-in-class, best-in-class oral treatment for mast cellmediated diseases including chronic spontaneous urticaria (CSU) and atopic dermatitis (AD), with additional possible applications in neuroinflammation. Both the CSU and AD markets are underserved by current treatment options, and alternative therapies offering improved efficacy, safety, and the convenience of oral dosing are needed to fill the unmet need in these patients..

EVO756是一种小分子MRGPRX2拮抗剂，正在开发作为一流、最佳的口服治疗药物，用于肥大细胞介导的疾病，包括慢性自发性荨麻疹（CSU）和特应性皮炎（AD），同时在神经炎症方面也有潜在应用。目前，CSU和AD市场现有治疗选择未能充分满足需求，这些患者需要新的替代疗法，以提供更高的疗效、安全性以及口服给药的便利性来填补未满足的需求。

About Evommune

关于Evommune

Evommune, Inc. is a clinical-stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases. The company is creating game-changing science with the goal of delivering therapies that halt disease progression and address disease symptoms. For more information, please visit .

Evommune公司是一家临床阶段的生物技术公司，致力于发现和开发治疗免疫介导的炎症性疾病的新方法。该公司正在创建颠覆性的科学成果，旨在提供能够阻止疾病进展并缓解疾病症状的治疗方法。欲了解更多信息，请访问。

www.evommune.com

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SOURCE Evommune, Inc

来源：Evommune公司

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