PALO ALTO, Calf., July 16, 2024 /PRNewswire/ -- Evommune, Inc., a clinical stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced positive results of its first-in-human proof-of-concept study with EVO756. By blocking MRGPRX2 activation and degranulation of mast cells, EVO756 has the potential to be a first-in-class oral treatment for a variety of mast cell-mediated diseases. Evommune is planning to present a comprehensive data set of this trial at a peer-review scientific meeting in the fall of 2024..

小牛帕洛阿尔托。，2024年7月16日，临床阶段的生物技术公司Evommune，Inc.发现并开发了治疗免疫介导的炎症性疾病的新方法，今天宣布了其首次使用EVO756进行的人体概念验证研究的积极结果。通过阻断肥大细胞的MRGPRX2活化和脱粒，EVO756有可能成为各种肥大细胞介导疾病的一流口服治疗药物。Evommune计划在2024年秋季的同行评审科学会议上提交该试验的全面数据集。。

'The data from our proof-of-concept trial exceeded our expectations, and we now plan to initiate multiple clinical trials of EVO756, including a Phase 2b study in chronic spontaneous urticaria (CSU) patients during the first half of 2025,' said Eugene Bauer, M.D., Chief Medical Officer at Evommune. 'We believe we have a novel, highly potent and selective agent that can be orally administered once daily, with broad opportunity for patients suffering from various mast-cell mediated diseases.'.

Evommune首席医疗官医学博士尤金·鲍尔（EugeneBauer）说：“我们概念验证试验的数据超出了我们的预期，我们现在计划启动EVO756的多项临床试验，包括2025年上半年对慢性自发性荨麻疹（CSU）患者进行2b期研究。”我们相信我们有一种新型，高效和选择性的药物，可以每天口服一次，为患有各种肥大细胞介导的疾病的患者提供了广泛的机会。”。

The proof-of-concept study is a randomized, double-blind, placebo-controlled single and multiple ascending dose (SAD and MAD) study in normal healthy adults and assessed the safety, tolerability, pharmacokinetics and pharmacodynamics/target engagement of orally administered EVO756. Doses from 1 mg to 500 mg were administered in ascending order across 7 cohorts of 8 subjects each (6 active, 2 placebo).

概念验证研究是一项在正常健康成年人中进行的随机，双盲，安慰剂对照的单次和多次递增剂量（SAD和MAD）研究，并评估了口服EVO756的安全性，耐受性，药代动力学和药效学/靶标参与。从1毫克到500毫克的剂量按升序在7个队列中给药，每个队列有8名受试者（6名活性，2名安慰剂）。

In the MAD cohorts completed to date, ascending doses of 10 mg, 30 mg, 100 mg and 240 mg BID have been administered across 4 cohorts of 16 subjects each (12 active and 4 placebo)..

在迄今为止完成的MAD队列中，已经在16名受试者（12名活性受试者和4名安慰剂）的4个队列中施用了10 mg，30 mg，100 mg和240 mg BID的递增剂量。。

The pharmacodynamic potential of EVO756 on mast cell degranulation was assessed in a skin challenge test, in which icatibant, a known ligand of the MRGPRX2 receptor, was administered intradermally, resulting in measurable skin responses in all MAD participants. Multiple experimental methods have determined that mast cell degranulation caused by icatibant is representative to changes associated with MRGPRX2 disease-relevant endogenous ligands.

在皮肤激发试验中评估了EVO756对肥大细胞脱颗粒的药效学潜力，其中皮内施用了已知的MRGPRX2受体配体依替班，从而在所有MAD参与者中产生了可测量的皮肤反应。多种实验方法已经确定，由icatibant引起的肥大细胞脱颗粒代表了与MRGPRX2疾病相关的内源性配体相关的变化。

This portion of the study allowed for an evaluation of target engagement and activity in a highly controlled setting and had the benefit of mimicking the potential impact of EVO756 versus placebo in inducible urticarias..

这部分研究允许在高度受控的环境中评估目标参与和活动，并有利于模仿EVO756与安慰剂对诱导性荨麻疹的潜在影响。。

'EVO756's excellent safety profile and potential for a once daily oral dosing provide continued excitement around this new class of therapies in inflammatory diseases. As expected, these data further support the hypothesis that blockade of the MRGPRX2 receptor and its subsequent downstream effect has the potential to treat the root cause of inflammation, offering greater relief than currently available treatments,' commented Sarbjit Saini, M.D., Professor of Medicine at Johns Hopkins University in Baltimore, Maryland..

“EVO756出色的安全性和每日一次口服给药的潜力为这类炎症性疾病的新疗法提供了持续的兴奋。马里兰州巴尔的摩市约翰·霍普金斯大学医学教授Sarbjit Saini评论道：“正如预期的那样，这些数据进一步支持了这样的假设，即阻断MRGPRX2受体及其随后的下游效应有可能治疗炎症的根本原因，比目前可用的治疗方法提供更大的缓解。”。。

About EVO756

关于EVO756

EVO756 is a potent, highly selective small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). MRGPRX2 is most abundantly found on mast cells and peripheral sensory neurons. MRGPRX2 can trigger IgE-independent activation (degranulation) via multiple ligands, which can lead to a variety of symptoms depending on the tissue that is affected.

EVO756是mas相关G蛋白偶联受体X2（MRGPRX2）的有效，高选择性小分子拮抗剂。MRGPRX2在肥大细胞和外周感觉神经元上最为丰富。MRGPRX2可以通过多种配体触发IgE非依赖性激活（脱粒），这可能导致多种症状，具体取决于受影响的组织。

Evommune's pre-clinical data demonstrates that by blocking activation of MRGPRX2 and degranulation of mast cells, EVO756 has the potential to be a first-in-class oral treatment for a variety of mast cell mediated diseases. In addition, due to its unique function on peripheral sensory neurons, EVO756 could provide fast relief of itch associated with inflammatory diseases, such as atopic dermatitis..

Evommune的临床前数据表明，通过阻断MRGPRX2的激活和肥大细胞的脱粒，EVO756有可能成为各种肥大细胞介导疾病的一流口服治疗药物。此外，由于其对外周感觉神经元的独特功能，EVO756可以快速缓解与炎症性疾病（如特应性皮炎）相关的瘙痒。。

About Evommune, Inc.

关于Evommune，Inc。

Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. For more information, please visit Evommune.com.

Evommune，Inc.，一家总部位于帕洛阿尔托的生物技术公司，正在创造改变游戏规则的科学，通过发现、开发和提供治疗症状和阻止进行性疾病的疗法来治疗免疫介导的炎症性疾病。有关更多信息，请访问Evommune.com。

SOURCE Evommune, Inc

SOURCE Evommune公司