Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) through Month 42 of the ATTRibute-CM Open Label Extension
BridgeBio Pharma (Nasdaq: BBIO) announced significant results from the ATTRibute-CM open label extension study of acoramidis through Month 42. The drug demonstrated a 44% reduction in cardiovascular mortality risk for patients with ATTR-CM. Additional key findings include a 46% hazard reduction in the composite outcome of cardiovascular mortality or first cardiovascular hospitalization.
The study showed that acoramidis, marketed as Attruby® in the US and BEYONTTRA® in Europe, achieved disease stabilization in about 50% of participants compared to less than 20% with placebo at Month 30, as measured by NT-proBNP levels. The drug demonstrated the fastest benefit observed in any Phase 3 ATTR-CM study to date, with results visible in just 3 months.
The data was presented at the European Society of Cardiology Congress 2025 in Madrid, highlighting acoramidis's potential as a transformative 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.
- 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
- None.
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
What's particularly remarkable is the durability and consistency of benefit across multiple endpoints. Beyond mortality reduction, acoramidis demonstrated a
The biomarker data provides compelling mechanistic support. NT-proBNP improvements or stabilization in approximately
For context, ATTR-CM has historically been a devastating diagnosis with limited treatment options. This TTR stabilizer, which achieves near-complete (≥
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
What differentiates these results is the comprehensive efficacy profile across multiple meaningful endpoints. The
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.
- Acoramidis demonstrated a significant reduction in risk of CVM through 42 months post-randomization, with a
- Acoramidis also demonstrated a significant
- Acoramidis demonstrated higher rates of disease stabilization or improvement versus disease progression as compared to placebo as reflected in change from baseline in NT-proBNP and NAC Stage
- In the ATTRibute-CM study, acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date in both ATTRv-CM and ATTRwt-CM patients
- In as few as 3 months, the time to first event (ACM or CVH) durably separated relative to placebo
- A
- A
- Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency and UK Medicines and Healthcare Products Regulatory Agency
PALO ALTO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented data from the ATTRibute-CM open label extension (OLE) through Month 42, which demonstrated a statistically significant reduction in CVM in the overall transthyretin amyloid cardiomyopathy (ATTR-CM) population. These data were presented in an oral presentation at the European Society of Cardiology (ESC) Congress 2025, taking place in Madrid, Spain from August 29 - September 1, 2025. Acoramidis is a selective, small molecule, orally administered, near-complete (≥
"These results from the ATTRibute-CM open-label extension study add to the growing body of evidence supporting acoramidis as a potentially transformative therapy for patients with ATTR-CM. At 42 months post-randomization, acoramidis achieved an impressive
Details from the oral presentation, Acoramidis Reduces Cardiovascular Mortality (CVM): Results at Month 42 from the ATTRibute-CM Open-Label Extension (OLE) Study, presented by Dr. Alexander, included:
- Acoramidis treatment administered for 42 months led to a
44% hazard reduction in CVM compared with the placebo to acoramidis treatment group - These findings demonstrate the long-term clinical benefits of acoramidis for reducing CVM in ATTR-CM, and the importance of early and sustained treatment
In addition to the oral presentation, two posters were shared with additional analyses at 30 month results from ATTRibute-CM. These findings included:
- Acoramidis-mediated Improvement in NT-proBNP at Month 30 Compared with Placebo in Patients with ATTR-CM: Results from the ATTRibute-CM Study, presented by Nitasha Sarswat, M.D. of UChicago Medicine, USA
- Acoramidis treatment resulted in improved or stable N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker used to assess heart failure and monitor its progression, at Month 30 in about
50% of study participants compared with fewer than20% with placebo, indicating a clinically meaningful improvement in NT-proBNP and better stabilization of their disease
- Acoramidis treatment resulted in improved or stable N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker used to assess heart failure and monitor its progression, at Month 30 in about
- Acoramidis Has a Beneficial Effect Compared with Placebo on Change from Baseline in NAC ATTR Stage at Month 30 in Patients with ATTR-CM: Results from the ATTRibute-CM Study, presented by Julian Gillmore, M.D., Ph.D., University College London's Centre for Amyloidosis, UK
- Acoramidis treatment resulted in a greater proportion of participants whose NAC Stage, a staging system developed by the National Amyloidosis Centre (NAC) to classify patients based on disease severity, protect against heart damage and improve cardiovascular function improved or remained stable at Month 30 compared with placebo, indicating better stabilization of their disease
Bayer, BridgeBio’s European licensing partner, will also have a poster shared by Francesco Cappelli, M.D. of Careggi University Hospital, Florence, IT, showing acoramidis achieved clinically meaningful improvements from baseline in NT-proBNP and/or six-minute walk distance test across 30 months in patients with ATTR-CM. In March 2024, BridgeBio entered into an exclusive licensing agreement with Bayer Consumer Care AG to commercialize BEYONTTRA in Europe for the treatment for ATTR‑CM.
Acoramidis is approved as Attruby by the U.S. FDA and is approved as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and the UK Medicines and Healthcare Products Regulatory Agency with all labels specifying near-complete stabilization of TTR.
More data on the benefit of Attruby for ATTR-CM patients are planned for future medical meetings.
About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter, Facebook, Instagram, and YouTube.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “potential,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements regarding the potential of acoramidis as a transformative therapy for patients with ATTR-CM and its potential to result in better stabilization of disease, reflect BridgeBio’s current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions it has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies as reflected in or suggested by these forward-looking statements are reasonable, it can give no assurance that such plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to: the risks associated with BridgeBio’s dependence on third parties for development; regulatory authorities requiring additional studies or data to support the continued or expanded commercialization of acoramidis; whether data and results meet regulatory requirements or are sufficient for continued development, review, or approval; and whether other regulatory agencies agree with BridgeBio’s strategies or data interpretations. These risks also include impacts from global health emergencies, such as delays in regulatory reviews and other activities, manufacturing and supply chain interruptions, adverse effects on healthcare systems, and disruption of the global economy; and the impacts of macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing inflation rates, and fluctuating interest rates on BridgeBio’s operations and expectations. Additional risks are described in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other filings with the U.S. Securities and Exchange Commission. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development
contact@bridgebio.com
(650)-789-8220
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FAQ
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