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Reported Sunday, BridgeBio Pharma Presented Results From The Exploratory Cardiac Magnetic Resonance Imaging Substudy Of ATTRibute-CM, Its Phase 3 Trial Of Acoramidis In ATTR-CM

Reported Sunday, BridgeBio Pharma Presented Results From The Exploratory Cardiac Magnetic Resonance Imaging Substudy Of ATTRibute-CM, Its Phase 3 Trial Of Acoramidis In ATTR-CM

週日報道，BridgeBio Pharma公佈了Attribute-CM的探索性心臟磁共振成像子研究的結果，這是其在ATTR-CM中對阿科拉米德的3期試驗
Benzinga ·  04/08 14:50
  • - In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression
  • - The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM
  • - These results are the first prospective, longitudinal evaluation of cardiac structure and function by CMR imaging in a double-blind, placebo-controlled, interventional study in ATTR-CM
  • - The findings from this study build upon positive results from BridgeBio's global ATTRibute-CM Phase 3 trial, wherein the primary endpoint was met (Win Ratio of 1.8) with a high statistical significance (p<0.0001); the substudy data are consistent with the cardiovascular clinical benefits observed with acoramidis
  • - Acoramidis was well-tolerated, with no safety signals of potential clinical concern observed
  • - BridgeBio's New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) with a PDUFA action date of November 29, 2024; a Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA), with an expected decision in 2025
  • -在這項探索性子研究中，與安慰劑相比，使用阿科拉米德治療可能改善心臟結構和功能，並可能出現心臟澱粉樣蛋白回歸
  • -數據表明，使用阿科拉米德靶向近乎完全的甲狀腺素（TTR）穩定劑可以實現 ATTR-CM 患者的心臟重塑和功能恢復
  • -這些結果是ATTR-CM的一項雙盲、安慰劑對照的介入性研究中首次通過CMR成像對心臟結構和功能進行前瞻性的縱向評估
  • -這項研究的發現建立在BridgeBio全球Atribie-CM 3期試驗的積極結果基礎上，該試驗達到了主要終點（勝率爲1.8），具有很高的統計學意義（p
  • -Acoramidis 耐受性良好，未觀察到潛在臨床問題的安全信號
  • -BridgeBio的新藥申請（NDA）已獲得美國食品藥品監督管理局（FDA）的批准，PDUFA的生效日期爲2024年11月29日；阿科拉米的上市許可申請（MAA）已被歐洲藥品管理局（EMA）接受，預計將在2025年做出決定

譯文內容由第三人軟體翻譯。


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