BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction.

结肠博尔德（BUSINESS WIRE）-领先的肌肉疾病生物制药公司Edgewise Therapeutics，Inc.（纳斯达克股票代码：EWTX）今天宣布在EDG-7500的1期临床试验中开始给药。EDG-7500是一流的口服，选择性心脏肌节调节剂，专门设计用于减慢早期收缩速度并解决与HCM和其他舒张功能障碍疾病相关的心脏舒张功能受损。

The Phase 1 trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults. The Company is also planning to begin a Phase 1b study of EDG-7500 in individuals with obstructive HCM in the first half of 2024..

第一阶段试验将评估EDG-7500在健康成人中的安全性，耐受性，药代动力学和药效学。该公司还计划在2024年上半年开始对阻塞性HCM患者进行EDG-7500的1b期研究。。

“Initiation of our Phase 1 study of EDG-7500, our first cardiovascular therapeutic candidate, is an important milestone for our company,” said Marc Semigran, M.D., Chief Development Officer, Edgewise Therapeutics. “I have spent over 30 years working to help patients with serious heart disease and am excited about the potential of EDG-7500 to help individuals affected by HCM, where significant unmet needs remain.”.

Edgewise Therapeutics首席开发官Marc Semigran博士说：“我们的第一个心血管治疗候选药物EDG-7500的第一阶段研究开始是我们公司的一个重要里程碑。”。“我花了30多年的时间来帮助患有严重心脏病的患者，并且对EDG-7500帮助受HCM影响的个人的潜力感到兴奋，因为HCM仍然存在重大未满足的需求。”。

Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics added, “We are pleased to add EDG-7500 to our growing clinical pipeline demonstrating our commitment to developing precision therapies for patients with severe genetic muscle diseases. EDG-7500 is representative of the robust discovery and development capabilities at Edgewise, and our commitment to patients with serious skeletal and cardiac muscle diseases.

Edgewise Therapeutics的总裁兼首席执行官Kevin Koch博士补充说，“我们很高兴将EDG-7500添加到我们不断增长的临床流程中，这表明我们致力于为严重遗传性肌肉疾病患者开发精确疗法.EDG-7500代表了Edgewise强大的发现和开发能力，以及我们对患者的承诺伴有严重的骨骼和心肌疾病。

As we mark this achievement, we look forward to initiating trials next year in HCM, and broadly in disorders of diastolic dysfunction.”.

当我们标志着这一成就时，我们期待明年在HCM以及广泛的舒张功能障碍中开始试验。”。

About EDG-7500 Phase 1 Clinical Trial

关于EDG-7500 1期临床试验

The Phase 1 trial is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults. Participants enrolled in this study will receive a single oral dose or multiple oral doses of EDG-7500 or a placebo.

第一阶段试验是一项随机，双盲，安慰剂对照，单次和多次递增剂量研究，评估EDG-7500在健康成人中的安全性，耐受性，药代动力学和药效学。参加本研究的参与者将接受单次口服剂量或多次口服剂量的EDG-7500或安慰剂。

To learn more about this study (NCT06011317), go to clinicaltrials.gov..

About Hypertrophic Cardiomyopathy

关于肥厚性梗阻型心肌病

HCM is the most common form of genetic heart disease with an estimated prevalence of as many as 700,000 people in the United States. The molecular underpinnings of HCM lead to abnormal cardiac sarcomeric protein function that eventually results in excessive contraction of the heart muscle, referred to as hypercontractility.

HCM是遗传性心脏病的最常见形式，在美国估计患病率高达700000人。HCM的分子基础导致异常的心肌肌节蛋白功能，最终导致心肌过度收缩，称为过度收缩。

Over time, hypercontractility increases the thickness (hypertrophy) of the heart’s left ventricular (LV) walls – the heart’s primary pumping chamber. Progressive hypertrophy eventually leads to a thick and stiff LV thereby reducing its ability to fill with blood during relaxation (diastole) and pump blood during contraction (systole).

随着时间的流逝，过度收缩会增加心脏左心室（LV）壁（心脏的主要抽气室）的厚度（肥大）。进行性肥大最终导致LV厚而僵硬，从而降低其在放松期间（舒张期）充满血液的能力和在收缩期间（收缩期）泵血。

A decreased volume of blood entering and leaving the LV causes shortness of breath, rapid heartbeat, chest pain, unexplained fatigue, dizziness, and syncope (loss of consciousness), which together cause HCM patients to become limited in their ability to perform activities of daily living. HCM can be diagnosed at any age; disease progression increases the risk of heart failure, stroke and atrial fibrillation.

进入和离开LV的血液量减少导致呼吸短促，心跳加速，胸痛，不明原因的疲劳，头晕和晕厥（意识丧失），这些共同导致HCM患者进行日常活动的能力受到限制生活。HCM可以在任何年龄被诊断出来；疾病进展会增加心力衰竭，中风和心房颤动的风险。

Despite advancements in the development of therapies to treat HCM, there is currently a significant unmet need for additional therapies to safely and more effectively treat the disease..

尽管治疗HCM的疗法的发展取得了进步，但目前仍存在重大的未满足需求，需要其他疗法来安全，更有效地治疗该疾病。。

About EDG-7500 for HCM

关于HCM的EDG-7500

EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that is advancing in a Phase 1 trial. The compound is designed to slow early contraction velocity and improve impaired cardiac relaxation. This novel mechanism is anticipated to have a broad therapeutic index that may facilitate fixed patient dosing and minimize monitoring during therapy.

EDG-7500是一流的口服，选择性心脏肌节调节剂，正在进行1期临床试验。该化合物旨在减缓早期收缩速度并改善心脏舒张受损。预计这种新机制具有广泛的治疗指数，其可以促进固定的患者剂量并最小化治疗期间的监测。

Preclinical data of EDG-7500 support beneficial activity in animal models of both obstructive HCM and cardiac diastolic dysfunction with minimal changes in left ventricular systolic performance. The Company plans to present preclinical data of EDG-7500 at a major cardiovascular meeting later this year..

EDG-7500的临床前数据支持阻塞性HCM和心脏舒张功能障碍的动物模型中的有益活性，而左心室收缩性能的变化很小。该公司计划在今年晚些时候的一次重大心血管会议上展示EDG-7500的临床前数据。。

About Edgewise Therapeutics

关于Edgewise疗法

Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The company’s deep expertise in muscle physiology is driving a new generation of first-in-class therapeutics. EDG-5506 is an orally administered skeletal myosin inhibitor in advanced clinical trials in patients with Becker, Duchenne, and Limb-Girdle muscular dystrophies as well as McArdle Disease.

Edgewise Therapeutics是一家领先的肌肉疾病生物制药公司，致力于开发针对肌营养不良和严重心脏病的新型疗法。该公司在肌肉生理学方面的深入专业知识正在推动新一代一流疗法的发展。EDG-5506是一种口服骨骼肌肌球蛋白抑制剂，用于Becker，Duchenne和肢带型肌营养不良症以及McArdle病患者的高级临床试验。

EDG-7500, currently in a Phase 1 trial, is a novel cardiac sarcomere modulator for the treatment of HCM and other disorders of cardiac diastolic dysfunction. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X (formerly Twitter), Facebook, Instagram and Threads..

EDG-7500目前处于1期试验中，是一种新型的心脏肌节调节剂，用于治疗HCM和其他心脏舒张功能障碍。Edgewise的整个团队致力于我们的使命：改变受严重肌肉疾病影响的患者和家庭的生活。要了解更多信息，请访问：www.edgewisetx.com或在LinkedIn，X（以前称为Twitter），Facebook，Instagram和线程上关注我们。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding EDG-7500; statements regarding Edgewise’s expectations relating to its preclinical studies and clinical trials, including the commencement of trials (including the Phase 1b study of EDG-7500 in individuals with obstructive HCM); and statements by Edgewise’s president and chief executive officer and chief development officer.

本新闻稿包含前瞻性声明，因为该术语在1933年“证券法”第27A条和1934年“证券交易法”第21E条中定义。本新闻稿中不纯粹是历史性的陈述是前瞻性陈述。这些前瞻性陈述除其他外，还包括关于EDG-7500的潜力和期望的陈述；关于Edgewise对其临床前研究和临床试验（包括开始试验（包括阻塞性HCM患者EDG-7500的1b期研究））的期望的陈述；以及Edgewise的总裁兼首席执行官和首席开发官的声明。

Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect.

诸如“相信”，“预期”，“计划”，“期望”，“意图”，“意愿”，“目标”，“潜力”之类的词语旨在识别前瞻性陈述。这里所包含的前瞻性陈述是基于Edgewise目前的预期，涉及可能永远不会实现或可能被证明是不正确的假设。

Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; the timing, progress and results of preclinical studies and clinical trials for EDG-7500; Edgewise’s.

由于存在许多风险和不确定性，实际结果可能与任何前瞻性声明中预测的结果有很大差异，包括但不限于：与发现过程相关的风险，开发和商业化安全有效地用作人类治疗药物并作为早期临床阶段公司运营的药物，包括Edgewise候选产品可能引起严重不良事件的可能性；Edgewise能够开发，启动或完成临床前研究和临床试验，获得任何候选产品的批准并将其商业化；EDG-7500临床前研究和临床试验的时机，进展和结果；埃德吉斯。