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.
加利福尼亞州紐瓦克/ACCESSWIRE/2024年5月14日/Protagonist Therapeutics, Inc.（納斯達克股票代碼：PTGX）（“主角” 或 “公司”）今天宣佈，來自rusfertide 2期REVIVE開放標籤延期研究的更多數據將成爲2024年6月13日至16日在西班牙馬德里舉行的歐洲血液學協會（EHA）大會口頭髮言的重點。根據對健康受試者進行的全面qt/qtC研究的結果，還將發表一份摘要，顯示rusfertide不存在qtC延期的情況。
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 演示詳情：
口頭陳述標題：研究真性紅細胞增多症患者（Pts）中Hepcidin模擬Rusfertide的2期Revive研究的最新長期結果：血細胞比容控制和治療性放血（Tp）頻率。
主持人：美國密歇根州安娜堡市密歇根大學血液學/腫瘤學系內科醫學系克里斯汀·佩蒂特醫學博士。
會議日期和時間：6月14日星期五第四，2024 年，14:45-16:00 CEST；Hall Goya 2
EHA Published Abstract Details:
EHA 發佈的摘要詳情：
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
口頭報告標題：Rusfertide（一種用於治療真性紅細胞增多症的仿製劑）不延長 qtC：一項針對健康受試者的詳盡的 qt/qtC 研究。
主要作者：Nishit Modi，主角療法臨床藥理學高級副總裁
About Protagonist
關於主角
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是一家生物製藥公司，其基於肽的新化學實體（NCE）rusfertide和 JNJ-2113（前身爲 PN-235）處於臨床開發的後期階段，均源自該公司的專有技術平台。作爲Protagonis與JNJ合作的一部分，Protagonis和JNJ的科學家共同發現了 PN-235（現稱爲 JNJ-2113），這是Protagonis與JNJ合作的一部分，並隨後進行了支持IND的臨床前和1期研究，JNJ負責進一步的臨床開發。IL-23RRusfertide是天然激素hepcidin的仿製品，是該公司目前處於全球第三階段開發計劃中的主要候選藥物。2期REVIVE研究的隨機部分是非盲化的，顯示出積極的結果，現已完成，開放標籤的擴展正在進行中。對真性紅細胞增多症中rusfertide的全球3期VERIFY研究正在進行中。根據與武田於2024年1月簽訂的全球合作和許可協議，Rusfertide將與武田共同開發和共同商業化。該協議將在《哈特-斯科特-羅迪諾法案》規定的任何適用等待期終止或到期時生效。
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at .
有關Proganist、其在研候選藥物和臨床研究的更多信息，請訪問該公司的網站，網址爲。
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SOURCE: Protagonist Therapeutics, Inc.
來源：Proganist Therapeutics, Inc.
譯文內容由第三人軟體翻譯。