Edgewise Therapeutics Doses First Patient In Phase 2 CIRRUS-HCM Trial Of EDG-7500 In Obstructive Hypertrophic Cardiomyopathy
Edgewise Therapeutics Doses First Patient In Phase 2 CIRRUS-HCM Trial Of EDG-7500 In Obstructive Hypertrophic Cardiomyopathy
Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today announced the dosing of the first patient in the Phase 2 CIRRUS-HCMtrial of EDG-7500. EDG-7500 is a novel 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. The Phase 2 trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of EDG-7500 in patients with obstructive HCM. Part A of the trial will evaluate single doses and Part B will evaluate multiple oral doses of EDG-7500 over 28 days.
領先的肌肉疾病生物製藥公司Edgewise Therapeutics, Inc.（納斯達克股票代碼：EWTX）今天宣佈，在 EDG-7500 Cirrus-HCM試驗的第二階段中，爲第一位患者服藥。EDG-7500 是一種新型的口服選擇性心臟肉瘤調節劑，專門設計用於減緩早期收縮速度並解決與 HCM 和其他舒張功能障礙相關的心臟鬆弛受損。2 期試驗將評估 EDG-7500 在阻塞性 HCM 患者中的安全性、耐受性、藥代動力學 (PK) 和藥效學。試驗 A 部分將評估單劑量，B 部分將評估 28 天內多次口服的 EDG-7500。
"Based on the strength of clinical and preclinical data to-date, we are advancing EDG-7500 into the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM," said Marc Semigran, M.D., Chief Development Officer, Edgewise Therapeutics. "We are encouraged by the effects of EDG-7500 observed in a translatable preclinical disease model of obstructive HCM. EDG-7500 demonstrated potent left ventricular (LV) outflow tract gradient relief while maintaining overall normal LV contractility. Importantly, in preclinical models of non-obstructive HCM, both acute and chronic administration of EDG-7500 has also been observed to be associated with significant improvements in ventricular filling and diastolic function."
Edgewise Therapeutics首席開發官馬克·塞米格蘭醫學博士表示：“根據迄今爲止強大的臨床和臨床前數據，我們正在將 EDG-7500 推向針對阻塞性HCM患者的2期CIRRUS-HCM試驗。”“在可翻譯的梗阻性 HCM 臨床前疾病模型中觀察到的 EDG-7500 的影響令我們感到鼓舞。EDG-7500 表現出強效的左心室 (LV) 流出道梯度緩解，同時保持了整體正常的左心室收縮力。重要的是，在無阻塞性 HCM 的臨床前模型中，還觀察到急性和慢性給藥 EDG-7500 與心室充盈和舒張功能的顯著改善有關。”
Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics added, "Advancing EDG-7500 into patients with obstructive HCM is an important milestone for Edgewise. EDG-7500 is representative of the robust discovery and development capabilities at Edgewise and our commitment to patients with serious muscle diseases."
Edgewise Therapeutics總裁兼首席執行官凱文·科赫博士補充說：“將 EDG-7500 推廣到阻塞性HCM患者中對Edgewise來說是一個重要的里程碑。EDG-7500 代表了 Edgewise 強大的發現和開發能力，也代表了我們對嚴重肌肉疾病患者的承諾。”
The Company expects to report data from the single dose arm of this trial and a Phase 1 trial of EDG-7500 in healthy volunteers in the third quarter of 2024. Furthermore, the Company expects to initiate a 28-day trial in patients with obstructive and non-obstructive HCM in the second half of 2024. The Company also expects to begin an open-label extension trial of EDG-7500 in the fourth quarter of 2024.
該公司預計將在2024年第三季度報告該試驗的單劑量組和針對健康志願者的 EDG-7500 一期試驗的數據。此外，該公司預計將在2024年下半年啓動一項針對阻塞性和非阻塞性HCM患者的爲期28天的試驗。該公司還預計將在2024年第四季度開始 EDG-7500 的開放標籤延期試驗。
About the Phase 2 CIRRUS-HCM Trial
關於第二階段 CIRRUS-HCM 試驗
CIRRUS-HCM is a multi-center, two-part, open-label trial of EDG-7500 in patients with obstructive HCM at up to 20 clinical sites in the U.S. The trial will evaluate the safety, tolerability, PK and pharmacodynamics of EDG-7500 in up to 30 adults with obstructive HCM. Participants enrolled in this trial will receive EDG-7500 as a single oral dose and may then receive multiple oral doses over 28 days. To learn more about this trial (NCT06347159), go to clinicaltrials.gov.
CIRRUS-HCM 是一項針對阻塞性 HCM 患者的 EDG-7500 的多中心、由兩部分組成的開放標籤試驗，在美國多達 20 個臨床部位。該試驗將評估 EDG-7500 在多達 30 名阻塞性 HCM 成人中的安全性、耐受性、PK 和藥效學。參加該試驗的參與者將以單一口服劑量接種 EDG-7500，然後可能在 28 天內接受多次口服劑量。要了解有關該試驗（NCT06347159）的更多信息，請訪問clinicaltrials.gov。
譯文內容由第三人軟體翻譯。