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.
周五，bridgebio pharma公司（纳斯达克：BBIO）展示了其阶段3 ATTRibute-Cm研究中评估acoramidis对所有原因死亡率（ACM）和复发心血管相关住院事件（CVH）终点的后期分析。
The data were shared at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024.
这些数据是在2024年心力衰竭协会（HFSA）年度科学会议上分享的。
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ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis.
ATTRibute-Cm旨在评估acoramidis的疗效和安全性。
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).
- 与安慰剂相比，应用负二项式回归模型（后期）（p=0.0005），acoramidis治疗在30个月内观察到了复合ACM和复发CVH事件的42%减少。
- 与安慰剂相比，acoramidis治疗在30个月内观察到了每位患者复合ACM和复发CVH事件的42%减少。
- 与安慰剂相比，应用Andersen-Gill模型（后期）（p=0.0008），acoramidis治疗在30个月内观察到了复合ACM和复发CVH事件的30.5%风险减少。
"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.
"这项事后分析进一步证明，通过使用acoramidis实现几乎完全的TTR稳定，可以改善ATTR-Cm患者的临床预后。在ATTRibute-Cm中观察到的减少住院和全因死亡率，加强了将acoramidis作为一线治疗的论据，考虑到它有潜力改善患者的整体生活质量，"南卡罗来纳州大学医学院的医学和心脏病学教授丹尼尔•裘治万博士说。
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.
转甲状腺素淀粉样变性（ATTR-CM）发生在肝脏产生不正常的转甲状腺素（TTR）蛋白质时。这些异常蛋白质（纤维蛋白）的团聚体堆积在心脏主泵室内。
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.
根据ATTRibute-Cm的结果，BridgeBio提交了一份FDA营销申请，已于2024年11月29日接受批准，以及一份申请欧洲药品管理局的营销授权申请，预计2025年会做出决定。
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年欧洲心脏病学协会上，提供了有关其三期ATTRibute-Cm和acoramidis在ATTR-Cm中开放性延伸研究的额外数据分析。
Price Action: BBIO stock is up 2.39% at $25.54 at last check Monday.
股价走势：BBIO股票在上周一最新交易时上涨了2.39%，报25.54美元。
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