Phase 1 study of MTX-463 initiated after FDA Clearance of IND

FDA批准IND后开始MTX-463的第一阶段研究

IND-enabling studies completed for second antibody program with Phase 1 expected to start in Q3

第二抗体计划的IND启用研究已完成，第一阶段预计将于第三季度开始

Clinical Advisory Board (CAB) of global experts in fibrosis formed to advance clinical development

全球纤维化专家临床咨询委员会（CAB）成立以促进临床发展

New preclinical data to be presented at upcoming medical meetings on WISP-1 and EphrinB2 and their roles in Idiopathic Pulmonary Fibrosis (IPF) and Systemic Sclerosis (SSc), respectively

即将在即将举行的WISP-1和EphrinB2医学会议上提交的新临床前数据及其在特发性肺纤维化（IPF）和系统性硬化（SSc）中的作用

BOSTON, May 6, 2024 /PRNewswire/ -- Mediar Therapeutics, Inc., a biotechnology company advancing a portfolio of first-in-class therapies that halt fibrosis progression, today announced that, following FDA clearance of its investigational new drug (IND) application, the first cohort of participants has been dosed in a Phase 1 trial evaluating the safety and tolerability of MTX-463.

波士顿，2024年5月6日/PRNewswire/--Mediar Therapeutics，Inc.，一家生物技术公司，推进了一系列一流的治疗方法，以阻止纤维化进展，今天宣布，在FDA批准其研究性新药（IND）申请后，第一批参与者已在评估MTX-463安全性和耐受性的第一阶段试验中服用。

MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling to address IPF and other fibrotic diseases. The Phase 1 study for MTX-463 is designed to assess its safety at multiple dose levels, tolerability, and pharmacokinetics, while also assessing the ability of MTX-463 to engage its target, WISP-1.

MTX-463是一流的人IgG1抗体，旨在中和WISP-1介导的纤维化信号传导，以解决IPF和其他纤维化疾病。MTX-463的第一阶段研究旨在评估其在多剂量水平，耐受性和药代动力学下的安全性，同时还评估MTX-463参与其靶标WISP-1的能力。

The trial is enrolling healthy participants and consists of staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts..

该试验正在招募健康参与者，由交错单次递增剂量（SAD）和多次递增剂量（MAD）队列组成。。

'Advancing our first-in-class portfolio to the clinic is an important milestone for Mediar, and an exciting moment envisioned by our founders at Mass General Brigham and advanced by our team,' said Mediar's Chief Executive Officer Rahul Ballal, Ph.D. 'MTX-463 is the first of two programs to begin clinical trials this year and we look forward to initiating a second Phase 1 study with our first-in-class anti-EphrinB2 molecule, MTX-474, in the third quarter.'.

Mediar首席执行官Rahul Ballal博士说：“将我们一流的投资组合推向临床，对Mediar来说是一个重要的里程碑，也是我们在马萨诸塞州布莱根将军的创始人所设想的一个激动人心的时刻，也是我们团队所推动的一个激动人心的时刻。”MTX-463是今年开始临床试验的两个项目中的第一个，我们期待着在第三季度启动我们第一个一流的抗EphrinB2分子MTX-474的第二阶段1研究。”。

As Mediar advances MTX-463 and MTX-474 into human studies, it will be guided by its clinical advisory board, comprising world renowned leaders in fibrosis across pulmonology, rheumatology, hepatology, and regulatory. 'With the formation of our CAB, we bring together a wealth of experience and expertise to help advance the clinical development of our pipeline as we work to address the significant unmet need in fibrosis,' said Mediar's Chief Medical Officer Jeff Bornstein, M.D..

随着Mediar将MTX-463和MTX-474推进人体研究，它将由其临床咨询委员会指导，该委员会由世界著名的肺病学、风湿病学、肝病学和监管学纤维化领导者组成。”Mediar首席医疗官杰夫·伯恩斯坦医学博士（Jeff Bornstein）说：“随着CAB的成立，我们汇集了丰富的经验和专业知识，帮助推进我们管道的临床开发，同时努力解决纤维化方面尚未满足的重大需求。”。。

The newly appointed members of the clinical advisory board are:

新任命的临床咨询委员会成员包括：

Flavia Castelino, M.D., Associate Professor of Medicine, Harvard Medical School, Division of Rheumatology, Massachusetts General Hospital

医学博士弗拉维亚·卡斯特利诺（FlaviaCastelino），哈佛医学院副教授，马萨诸塞州总医院风湿病科

Lara Dimick-Santos, M.D., Medical Director, CTI Clinical Trial & Consulting Services, former FDA medical reviewer

医学博士Lara Dimick Santos，CTI临床试验与咨询服务医学总监，前FDA医学审稿人

Scott Friedman, M.D., Dean for Therapeutic Discovery, Fishberg Professor of Medicine, Director, Institute for Liver Research, Icahn School of Medicine at Mount Sinai

斯科特·弗里德曼（ScottFriedman），医学博士，治疗发现院长，菲斯堡医学教授，西奈山伊坎医学院肝脏研究所所长

Robert Lafyatis, M.D., Professor of Medicine, Division of Rheumatology & Clinical Immunology, University of Pittsburgh Medical Center

Robert Lafyatis，医学博士，匹兹堡大学医学中心风湿病与临床免疫学系医学教授

Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, University of California San Diego

罗希特·卢姆巴（Rohit Loomba），医学博士，MHSc，医学教授，加利福尼亚大学圣地亚哥分校胃肠学和肝病学系主任

Toby Maher, M.D., Ph.D., Professor of Medicine, Director of Interstitial Lung Diseases, University of Southern California

Toby Maher，医学博士，博士，医学教授，南加州大学间质性肺病主任

Sydney Montesi, M.D., Assistant Professor of Medicine, Harvard Medical School, Pulmonary and Critical Care Medicine, Massachusetts General Hospital

医学博士Sydney Montesi，哈佛医学院医学助理教授，马萨诸塞州总医院肺部和重症监护医学

John Varga, M.D., Professor of Medicine, Chief of the Division of Rheumatology, University of Michigan

医学博士约翰·瓦尔加（JohnVarga），医学教授，密歇根大学风湿病系主任

In addition, new preclinical data supporting the application of MTX-463 in IPF will be presented at the 2024 American Thoracic Society (ATS) meeting in San Diego, May 17-22, 2024. Data supporting MTX-474 in Systemic Sclerosis (SSc) will be presented in an oral presentation at the Congress on the EPH/Ephrin System in Parma, Italy, May 16-17, 2024..

此外，支持MTX-463在IPF中应用的新临床前数据将于2024年5月17日至22日在圣地亚哥举行的2024年美国胸科学会（ATS）会议上提交。支持MTX-474在系统性硬化症（SSc）中的数据将在2024年5月16日至17日在意大利帕尔马举行的EPH/Ephrin系统大会上进行口头介绍。。

About MTX-463

关于MTX-463

MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP-1). WISP-1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, measurable in human blood, and correlates with disease severity. Initial data indicates that MTX-463 neutralizes WISP-1-mediated fibrotic signaling that spans several fibrotic indications and significantly reduced fibrosis in vitro and in preclinical mouse models.

MTX-463是针对WNT1诱导型信号通路蛋白-1（WISP-1）开发的一流人IgG1抗体。WISP-1是一种分泌的基质细胞蛋白，显示在纤维化进展中具有相关作用，可在人体血液中测量，并与疾病严重程度相关。最初的数据表明，MTX-463中和了WISP-1介导的纤维化信号，该信号跨越了几种纤维化适应症，并在体外和临床前小鼠模型中显着降低了纤维化。

MXT-463 is currently in Phase 1 clinical evaluation to assess its safety and tolerability in healthy participants (NCT06401213)..

MXT-463目前正在进行第一阶段临床评估，以评估其在健康参与者中的安全性和耐受性（NCT06401213）。。

About MTX-474

关于MTX-474

MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes the onset and progression of fibrosis. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodeling.

MTX-474是一流的人类IgG1抗体，旨在中和导致纤维化发作和进展的EphrinB2信号传导。Ephrin配体和Eph受体介导涉及组织纤维化的生物学过程，包括细胞迁移，肌成纤维细胞活化和组织重塑。

A growing body of evidence has implicated EphrinB2 in the fibrosis of the skin, lungs, and heart. Expression of EphrinB2 and its receptors are measurable in human blood and correlates with disease severity. Initiation of Phase 1 clinical studies for this program is anticipated in Q3-2024..

越来越多的证据表明EphrinB2与皮肤，肺和心脏的纤维化有关。EphrinB2及其受体的表达在人血液中是可测量的，并且与疾病的严重程度相关。预计该项目的第一阶段临床研究将于2024年第三季度开始。。

About Mediar Therapeutics

关于Mediar Therapeutics

Mediar Therapeutics is pioneering a new approach to fibrosis treatment that halts the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression.

Mediar Therapeutics开创了一种新的纤维化治疗方法，可以从不同的来源阻止疾病-肌成纤维细胞，肌成纤维细胞是纤维化的关键致病细胞，可驱动瘢痕形成，疾病进展，最终导致器官衰竭。Mediar是基于对纤维化发病和进展的复杂科学的深入理解而成立的。

By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact info@mediartx.com or follow us on LinkedIn..

通过将新靶点与可靠，易于检测的血液生物标志物和熟悉的方式相结合，Mediar正在探索临床开发中纤维化治疗的前进道路。有关更多信息，请联系info@mediartx.com或者在LinkedIn上关注我们。。

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SOURCE Mediar Therapeutics

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