BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market
BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market
The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.On Monday, BridgeBio Pharma, Inc. (NASDAQ:BBIO) presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association Scientific Sessions.
在週一，bridgebio pharma公司（納斯達克：BBIO）在美國心臟協會科學會議上展示了ATTRibute-Cm開放標籤擴展（OLE）研究中acoramidis在ATTR-Cm中的初步結果。
ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational small-molecule stabilizer of transthyretin (TTR) gene.
ATTRibute-Cm的設計旨在評估acoramidis的療效和安全性，這是一種針對轉鐵蛋白（TTR）基因的研究性小分子穩定劑。
Also Read: BridgeBio Pharma's Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease
另請閱讀：bridgebio pharma的主要候選藥物可以減少某些類型心臟病患者的死亡率及相關住院率
The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.
該OLE研究涉及330名完成了爲期30個月的ATTRibute-Cm三期研究的參與者。
Key initial results from the OLE study show that continuous treatment with acoramidis led to:
來自OLE研究的關鍵初步結果表明，連續使用acoramidis治療導致：
- A confirmed sustained improvement relative to placebo in time to the first event ( cardiovascular-related hospitalizations (CVH) or All-Cause Mortality (ACM)) starting at Month 3 in ATTRibute-CM
- A statistically significant reduction in ACM alone of 36% by Month 36 (p=0.009) and 34% by Month 42 (p=0.006).
- A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.
- Acoramidis continues to be well tolerated, with no new clinically significant safety signals identified in this long-term evaluation.
- 相對於安慰劑，在第3個月開始的ATTRibute-CM中，首次事件（與心血管相關的住院（CVH）或所有原因的死亡（ACM））的時間確認持續改善。
- 在第36個月（p=0.009）時，ACm單獨顯著減少了36%，在第42個月（p=0.006）時減少了34%。
- 在第36個月，ACm和CVH的綜合顯著減少了46%，在第42個月減少了48%，在ATTRibute-Cm的第30個月之前呈現的42%的減少基礎上進一步改善。
- Acoramidis在這項長期評估中繼續被良好耐受，沒有發現新的臨床顯著安全信號。
The OLE data build on previously reported results from ATTRibute-CM in which acoramidis demonstrated clinically important treatment effects on mortality, CVH, and quality of life, further supporting that greater transthyretin (TTR) stabilization can improve clinical outcomes for patients.
OLE數據建立在ATTRibute-Cm之前報告的結果基礎上，其中acoramidis在死亡率、心血管健康和生活質量方面顯示出臨床重要的治療效果，進一步支持了更好的轉甲狀腺素(TTR)穩定性可以改善患者的臨床結果。
This included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.
這包括第30個月相對於安慰劑的心血管健康累計發生頻率減少50%。
BridgeBio's marketing application is under FDA review, with a PDUFA action date of November 29, 2024. It also has a marketing application to the European Medicines Agency, with a decision expected in 2025.
bridgebio pharma的營銷申請正在FDA審查中，PDUFA行動日期爲2024年11月29日。它還有一項向歐洲藥品管理局提交的營銷申請，預期在2025年作出決定。
BridgeBio has granted Bayer AG (OTC:BAYRY) exclusive rights to commercialize ceramides for ATTR-CM in Europe.
bridgebio pharma已授予拜耳(adr)在歐洲對ATTR-Cm的酰胺類藥物的獨家商業化權利。
William Blair writes that reducing overall mortality is crucial for competing in the ATTR-CM market against Pfizer Inc's (NYSE:PFE) tafamidis, which already includes proven mortality benefits on its label from the ATTR-ACT trial.
William Blair寫道，降低整體死亡率對於與輝瑞公司(紐交所:PFE)的tafamidis在ATTR-Cm市場競爭至關重要，後者已經在其標籤上包含了來自ATTR-ACt試驗的已證明的死亡率益處。
The analyst writes, "While Bridge Bio continues to publish analyses of acoramidis demonstrating the TTR stabilizer is safe and efficacious, we deem an on-label claim to all-cause mortality benefit as an important factor for market share in the lucrative, but competitive, ATTR-CM space."
分析師寫道："雖然bridgebio pharma繼續發佈關於acoramidis的分析，證明這種TTR穩定劑是安全和有效的，但我們認爲針對所有原因死亡率利益的標籤主張是市場份額在這個有利可圖但競爭激烈的ATTR-Cm領域的重要因素。"
Price Action: BBIO stock is up 0.85% at $22.54 at the last check on Tuesday.
價格動態：截至週二最後檢查，BBIO股票上漲0.85%，報22.54美元。
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譯文內容由第三人軟體翻譯。
