BridgeBio Pharma's Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease
BridgeBio Pharma's Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease
ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis.On Friday, BridgeBio Pharma, Inc. (NASDAQ:BBIO) presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) events in its Phase 3 ATTRibute-CM study in ATTR-CM.
週五，bridgebio pharma公司（納斯達克：BBIO）展示了其階段3 ATTRibute-Cm研究中評估acoramidis對所有原因死亡率（ACM）和復發心血管相關住院事件（CVH）終點的後期分析。
The data were shared at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024.
這些數據是在2024年心力衰竭協會（HFSA）年度科學會議上分享的。
Also Read: BridgeBio Pharma Seeks Partner To Develop Gene Therapy For Inherited Condition.
另請閱讀：bridgebio pharma尋求合作伙伴開發遺傳條件的基因療法。
ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis.
ATTRibute-Cm旨在評估acoramidis的療效和安全性。
The analysis included:
分析包括：
- A 42% reduction in composite ACM and recurrent CVH events at 30 months was observed with acoramidis treatment compared to placebo by applying a negative binomial regression model (post-hoc) (p=0.0005).
- A 42% reduction in ACM and recurrent CVH events per patient was observed over 30 months with acoramidis treatment compared to placebo.
- A 30.5% hazard reduction in ACM and recurrent CVH events at 30 months was observed with acoramidis treatment compared to placebo by applying the Andersen-Gill model (post-hoc) (p=0.0008).
- 與安慰劑相比，應用負二項式回歸模型（後期）（p=0.0005），acoramidis治療在30個月內觀察到了複合ACM和復發CVH事件的42%減少。
- 與安慰劑相比，acoramidis治療在30個月內觀察到了每位患者複合ACM和復發CVH事件的42%減少。
- 與安慰劑相比，應用Andersen-Gill模型（後期）（p=0.0008），acoramidis治療在30個月內觀察到了複合ACM和復發CVH事件的30.5%風險減少。
"This post-hoc analysis provides further evidence that near-complete TTR stabilization with acoramidis can improve clinical outcomes for patients with ATTR-CM. The reduction of hospitalizations and all-cause mortality seen in ATTRibute-CM heightens the case for acoramidis as a first-line therapy, given its potential to improve the overall quality of life for patients," said Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina.
"這項事後分析進一步證明，通過使用acoramidis實現幾乎完全的TTR穩定，可以改善ATTR-Cm患者的臨床預後。在ATTRibute-Cm中觀察到的減少住院和全因死亡率，加強了將acoramidis作爲一線治療的論據，考慮到它有潛力改善患者的整體生活質量，"南卡羅來納州大學醫學院的醫學和心臟病學教授丹尼爾•裘治萬博士說。
Transthyretin amyloidosis (ATTR-CM) occurs when the liver produces faulty transthyretin (TTR) proteins. Clumps of these abnormal proteins (fibrils) build up in the heart's main pumping chamber.
轉甲狀腺素澱粉樣變性（ATTR-CM）發生在肝臟產生不正常的轉甲狀腺素（TTR）蛋白質時。這些異常蛋白質（纖維蛋白）的團聚體堆積在心臟主泵室內。
Based on the results from ATTRibute-CM, BridgeBio submitted an FDA marketing application, which has been accepted with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025.
根據ATTRibute-Cm的結果，BridgeBio提交了一份FDA營銷申請，已於2024年11月29日接受批准，以及一份申請歐洲藥品管理局的營銷授權申請，預計2025年會做出決定。
In August, BridgeBio Pharma presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology 2024.
8月份，BridgeBio Pharma在2024年歐洲心臟病學協會上，提供了有關其三期ATTRibute-Cm和acoramidis在ATTR-Cm中開放性延伸研究的額外數據分析。
Price Action: BBIO stock is up 2.39% at $25.54 at last check Monday.
股價走勢：BBIO股票在上週一最新交易時上漲了2.39%，報25.54美元。
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譯文內容由第三人軟體翻譯。