Protagonist Therapeutics Announces Oral Presentation on Long-Term Follow-up of Rusfertide Phase 2 REVIVE Study Open Label Extension at the European Hematology Association 2024 Congress
Protagonist Therapeutics Announces Oral Presentation on Long-Term Follow-up of Rusfertide Phase 2 REVIVE Study Open Label Extension at the European Hematology Association 2024 Congress
NEWARK, CA / ACCESSWIRE / May 14, 2024 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or the "Company") today announced that additional data from the rusfertide Phase 2 REVIVE open label extension study will be the focus of an oral presentation at the European Hematology Association (EHA) Congress being held in Madrid, Spain from June 13-16, 2024. There will also be a published abstract showing the absence of QTc prolongation with rusfertide based on the results from the thorough QT/QTc study conducted in healthy subjects.
加利福尼亚州纽瓦克/ACCESSWIRE/2024年5月14日/Protagonist Therapeutics, Inc.（纳斯达克股票代码：PTGX）（“主角” 或 “公司”）今天宣布，来自rusfertide 2期REVIVE开放标签延期研究的更多数据将成为2024年6月13日至16日在西班牙马德里举行的欧洲血液学协会（EHA）大会口头发言的重点。根据对健康受试者进行的全面qt/qtC研究的结果，还将发表一份摘要，显示rusfertide不存在qtC延期的情况。
EHA Presentation Details:
Oral Presentation Title: Updated Long-Term Results from the Phase 2 Revive Study Investigating the Hepcidin Mimetic Rusfertide in Polycythemia Vera Patients (Pts): Hematocrit Control and Therapeutic Phlebotomy (Tp) Frequency.
Presenter: Kristen M. Pettit, MD, Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA.
Date and Time of Conference Session: Friday, June 14th, 2024, 14:45 - 16:00 CEST; Hall Goya 2
EHA 演示详情：
口头陈述标题：研究真性红细胞增多症患者（Pts）中Hepcidin模拟Rusfertide的2期Revive研究的最新长期结果：血细胞比容控制和治疗性放血（Tp）频率。
主持人：美国密歇根州安娜堡市密歇根大学血液学/肿瘤学系内科医学系克里斯汀·佩蒂特医学博士。
会议日期和时间：6月14日星期五第四，2024 年，14:45-16:00 CEST；Hall Goya 2
EHA Published Abstract Details:
EHA 发布的摘要详情：
Oral Presentation Title: Absence of QTc Prolongation with Rusfertide, a Hepcidin Mimetic for the Treatment of Polycythemia Vera: a Thorough QT/QTc Study in Healthy Subjects.
Lead Author: Nishit Modi, SVP of Clinical Pharmacology, Protagonist Therapeutics
口头报告标题：Rusfertide（一种用于治疗真性红细胞增多症的仿制剂）不延长 qtC：一项针对健康受试者的详尽的 qt/qtC 研究。
主要作者：Nishit Modi，主角疗法临床药理学高级副总裁
About Protagonist
关于主角
Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. The agreement will be effective upon the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.
Protagonist Therapeutics是一家生物制药公司，其基于肽的新化学实体（NCE）rusfertide和 JNJ-2113（前身为 PN-235）处于临床开发的后期阶段，均源自该公司的专有技术平台。作为Protagonis与JNJ合作的一部分，Protagonis和JNJ的科学家共同发现了 PN-235（现称为 JNJ-2113），这是Protagonis与JNJ合作的一部分，并随后进行了支持IND的临床前和1期研究，JNJ负责进一步的临床开发。IL-23RRusfertide是天然激素hepcidin的仿制品，是该公司目前处于全球第三阶段开发计划中的主要候选药物。2期REVIVE研究的随机部分是非盲化的，显示出积极的结果，现已完成，开放标签的扩展正在进行中。对真性红细胞增多症中rusfertide的全球3期VERIFY研究正在进行中。根据与武田于2024年1月签订的全球合作和许可协议，Rusfertide将与武田共同开发和共同商业化。该协议将在《哈特-斯科特-罗迪诺法案》规定的任何适用等待期终止或到期时生效。
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at .
有关Proganist、其在研候选药物和临床研究的更多信息，请访问该公司的网站，网址为。
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科里·戴维斯博士
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SOURCE: Protagonist Therapeutics, Inc.
来源：Proganist Therapeutics, Inc.
译文内容由第三方软件翻译。