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BridgeBio Pharma (Nasdaq: BBIO) just dropped some eye-opening data from its ATTRibute-CM open label extension study on acoramidis, and it’s looking pretty good for the biotech firm. The study, which followed patients for 42 months, showed a whopping 44% reduction in cardiovascular mortality risk for those battling ATTR-CM, a serious and often fatal heart condition.
But wait, there’s more: the data also revealed a 46% hazard reduction in the composite outcome of cardiovascular mortality or first cardiovascular hospitalization. In layman’s terms, acoramidis isn’t just keeping patients alive; it’s also keeping them out of the hospital.
The drug, already marketed as Attruby® in the US and BEYONTTRA® in Europe, appears to be stabilizing the disease in roughly 50% of participants, compared to less than 20% with a placebo at Month 30, according to NT-proBNP levels. What’s particularly impressive? The speed. Acoramidis demonstrated the fastest benefit observed in any Phase 3 ATTR-CM study to date, with positive changes visible in just 3 months.
The data, unveiled at the European Society of Cardiology Congress 2025 in Madrid, underscores acoramidis’s potential as a game-changing therapy for ATTR-CM patients.
BridgeBio Pharma (Nasdaq: BBIO) ha annunciato risultati significativi dallo studio di estensione open label ATTRibute-CM sull’acoramidis fino al mese 42. Il farmaco ha mostrato una riduzione del 44% del rischio di mortalità cardiovascolare nei pazienti con ATTR-CM. Tra gli altri risultati chiave, si è osservata una riduzione del 46% del rischio per l’endpoint composito di mortalità cardiovascolare o prima ospedalizzazione cardiovascolare.
Lo studio ha evidenziato che l’acoramidis, commercializzato come Attruby® negli USA e BEYONTTRA® in Europa, ha ottenuto la stabilizzazione della malattia in circa il 50% dei partecipanti rispetto a meno del 20% con placebo al mese 30, misurata sui livelli di NT-proBNP. Il farmaco ha mostrato il beneficio più rapido osservato finora in uno studio di Fase 3 su ATTR-CM, con risultati visibili già dopo 3 mesi.
I dati sono stati presentati al Congresso 2025 della European Society of Cardiology a Madrid, sottolineando il potenziale trasformativo dell’acoramidis per i pazienti con ATTR-CM.
BridgeBio Pharma (Nasdaq: BBIO) anunció resultados significativos del estudio de extensión abierto ATTRibute-CM con acoramidis hasta el mes 42. El fármaco mostró una reducción del 44% del riesgo de mortalidad cardiovascular en pacientes con ATTR-CM. Otros hallazgos clave incluyen una reducción del 46% en el riesgo del resultado compuesto de mortalidad cardiovascular o primera hospitalización cardiovascular.
El estudio demostró que acoramidis, comercializado como Attruby® en EE. UU. y BEYONTTRA® en Europa, logró la estabilización de la enfermedad en aproximadamente el 50% de los participantes frente a menos del 20% con placebo en el mes 30, medida por los niveles de NT-proBNP. El fármaco mostró el beneficio más rápido observado hasta la fecha en un ensayo de Fase 3 de ATTR-CM, con resultados visibles en solo 3 meses.
Los datos se presentaron en el Congreso 2025 de la European Society of Cardiology en Madrid, destacando el potencial transformador de acoramidis para los pacientes con ATTR-CM.
BridgeBio Pharma (Nasdaq: BBIO)는 acoramidis의 ATTRibute-CM 공개연장 연구 결과를 42개월까지 발표했습니다. 이 약물은 ATTR-CM 환자에서 심혈관 사망 위험을 44% 감소시켰습니다. 추가 주요 결과로는 심혈관 사망 또는 첫 심혈관 입원을 포함한 복합 결과에서 위험 감소 46%가 보고되었습니다.
연구는 acoramidis가 미국에서 Attruby®, 유럽에서 BEYONTTRA®로 판매되며, NT-proBNP 수치로 측정한 바에 따르면 30개월 시점에 약 50%의 참가자에서 질병 안정화를 달성한 반면 위약군은 20% 미만에 그쳤음을 보여주었습니다. 이 약물은 지금까지 ATTR-CM 3상 연구 중 가장 빠른 임상적 혜택을 보였으며, 결과는 단 3개월 만에 관찰되었습니다.
이 데이터는 마드리드에서 열린 2025년 유럽심장학회(European Society of Cardiology) 학술대회에서 발표되었으며, ATTR-CM 환자에 대한 acoramidis의 변혁적 가능성을 강조했습니다.
BridgeBio Pharma (Nasdaq: BBIO) a annoncé des résultats significatifs de l’étude d’extension en ouvert ATTRibute-CM sur l’acoramidis jusqu’au mois 42. Le médicament a montré une réduction de 44% du risque de mortalité cardiovasculaire chez les patients atteints d’ATTR‑CM. Parmi les autres résultats clés, on note une réduction du risque de 46% pour le critère composite mortalité cardiovasculaire ou première hospitalisation cardiovasculaire.
L’étude a montré que l’acoramidis, commercialisé sous les noms Attruby® aux États‑Unis et BEYONTTRA® en Europe, a permis une stabilisation de la maladie chez environ 50% des participants contre moins de 20% sous placebo au mois 30, mesurée par les niveaux de NT‑proBNP. Le médicament a démontré le bénéfice le plus rapide observé à ce jour dans une étude de phase 3 sur l’ATTR‑CM, avec des résultats visibles dès 3 mois.
Les données ont été présentées lors du congrès 2025 de la European Society of Cardiology à Madrid, mettant en avant le potentiel transformateur de l’acoramidis pour les patients atteints d’ATTR‑CM.
BridgeBio Pharma (Nasdaq: BBIO) gab bedeutende Ergebnisse der offenen Verlängerungsstudie ATTRibute-CM mit Acoramidis bis Monat 42 bekannt. Das Medikament zeigte eine 44%ige Reduktion des Risikos für kardiovaskulären Tod bei Patienten mit ATTR-CM. Weitere zentrale Befunde umfassen eine 46%ige Risikosenkung für das kombinierte Endpunktkriterium aus kardiovaskulärem Tod oder erster kardiovaskulärer Hospitalisierung.
Die Studie zeigte, dass Acoramidis, vermarktet als Attruby® in den USA und BEYONTTRA® in Europa, bei etwa 50% der Teilnehmenden eine Krankheitsstabilisierung erreichte gegenüber weniger als 20% unter Placebo zum Monat 30, gemessen an NT-proBNP-Werten. Das Medikament zeigte den bislang schnellsten Nutzen in einer Phase‑3‑Studie zu ATTR‑CM, mit ersten Ergebnissen bereits nach 3 Monaten.
Die Daten wurden auf dem Kongress 2025 der European Society of Cardiology in Madrid vorgestellt und heben das potenziell transformativen Therapiepotenzial von Acoramidis für ATTR-CM-Patienten hervor.
Positive
- 44% reduction in cardiovascular mortality risk at 42 months
- 46% hazard reduction in composite cardiovascular outcomes
- 50% of patients showed disease stabilization vs. less than 20% with placebo
- Fastest benefit observed in any Phase 3 ATTR-CM study (3 months)
- Regulatory approvals secured in US, Europe, Japan, and UK
Insights
BridgeBio’s acoramidis shows impressive 44% reduction in cardiovascular mortality in ATTR-CM patients at 42 months, confirming long-term efficacy.
The latest data from BridgeBio’s ATTRibute-CM open label extension (OLE) represents a significant advancement in ATTR-CM treatment. The observed 44% reduction in cardiovascular mortality risk through 42 months establishes acoramidis as potentially best-in-class for this deadly condition.
What’s particularly remarkable is the durability and consistency of benefit across multiple endpoints. Beyond mortality reduction, acoramidis demonstrated a 46% hazard reduction in the composite of cardiovascular mortality or first cardiovascular hospitalization. The rapid onset of action is clinically meaningful – showing benefit separation from placebo in as few as 3 months – addressing a critical need for these rapidly progressing patients.
The biomarker data provides compelling mechanistic support. NT-proBNP improvements or stabilization in approximately 50% of treated patients (versus 20% with placebo) confirms the drug’s ability to reduce cardiac wall stress. Similarly, the favorable NAC staging outcomes demonstrate acoramidis can halt or reverse disease progression.
For context, ATTR-CM has historically been a devastating diagnosis with limited treatment options. This TTR stabilizer, which achieves near-complete (≥90%) stabilization of the transthyretin protein, prevents the misfolding that leads to amyloid deposition in cardiac tissue. The multi-regional regulatory approvals (US, Europe, Japan, UK) reflect the strength of the clinical package.
These 42-month data address the crucial question of durability, suggesting early treatment initiation translates to sustained benefit – potentially altering the natural history of this progressive disease.
The 42-month data from BridgeBio’s ATTRibute-CM extension study represents a major clinical and commercial inflection point for acoramidis in the ATTR-CM market. The statistically significant 44% reduction in cardiovascular mortality not only validates the drug’s efficacy but strengthens its competitive positioning against established and emerging therapies.
What differentiates these results is the comprehensive efficacy profile across multiple meaningful endpoints. The 46% hazard reduction in the composite outcome of mortality/hospitalization, 42% reduction in mortality and recurrent hospitalizations, and 50% reduction in hospitalization frequency all point to robust real-world clinical utility. The biomarker improvements in NT-proBNP and favorable NAC staging outcomes provide objective evidence of disease modification.
The regulatory success across major markets (US FDA, European Commission, Japanese PMDA, UK MHRA) positions BridgeBio for global commercialization. The European licensing agreement with Bayer creates a strong partnership with an established cardiovascular leader, potentially accelerating European market penetration.
The rapid onset of clinical benefit (separation from placebo at 3 months) represents a key competitive advantage and should support favorable positioning in treatment guidelines. For ATTR-CM patients facing a progressive, life-threatening condition, this accelerated timeline to benefit could drive physician preference and adoption.
These compelling long-term data should strengthen payer negotiations and support favorable reimbursement decisions, particularly given the reduction in hospitalizations which directly impacts healthcare costs.
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