Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM
BridgeBio Pharma (Nasdaq: BBIO) presented groundbreaking data from the ATTRibute-CM study showing that acoramidis, their oral TTR stabilizer, demonstrates rapid efficacy in treating ATTR-CM (transthyretin amyloid cardiomyopathy). The drug showed significant cardiovascular benefits within the first month of treatment.
Key findings include a 49% hazard reduction in cardiovascular mortality or recurrent hospitalizations through Month 30 (p<0.0001), with 53 events avoided per 100 treated participants. At Month 42, continuous acoramidis treatment reduced cardiovascular mortality by 45% compared to placebo-to-acoramidis switch (p=0.0011).
Acoramidis, marketed as Attruby® in the US and BEYONTTRA® in Europe, Japan, and the UK, has received regulatory approval with labels specifying near-complete TTR stabilization.
BridgeBio Pharma (Nasdaq: BBIO) ha presentato dati rivoluzionari dallo studio ATTRibute-CM, mostrando che acoramidis, il loro stabilizzatore orale della TTR, dimostra un’efficacia rapida nel trattamento dell’ATTR-CM (cardiomiopatia amiloidotica da transtiretina). Il farmaco ha evidenziato benefici cardiovascolari significativi entro il primo mese di trattamento.
Tra i principali risultati vi è una riduzione del rischio del 49% di mortalità cardiovascolare o di ri-ospedalizzazioni entro il mese 30 (p<0,0001), con 53 eventi evitati ogni 100 partecipanti trattati. Al mese 42, il trattamento continuo con acoramidis ha ridotto la mortalità cardiovascolare del 45% rispetto al confronto tra placebo e passaggio a acoramidis (p=0,0011).
Acoramidis, commercializzato come Attruby® negli USA e BEYONTTRA® in Europa, Giappone e Regno Unito, ha ottenuto l’approvazione regolatoria con etichette che specificano una stabilizzazione quasi completa della TTR.
BridgeBio Pharma (Nasdaq: BBIO) presentó datos innovadores del estudio ATTRibute-CM que muestran que acoramidis, su estabilizador oral de TTR, demuestra una eficacia rápida en el tratamiento de ATTR-CM (miocardiopatía amiloidea por transtiretina). El fármaco mostró beneficios cardiovasculares significativos dentro del primer mes de tratamiento.
Los hallazgos clave incluyen una reducción del riesgo del 49% de mortalidad cardiovascular o hospitalizaciones recurrentes hasta el Mes 30 (p<0,0001), con 53 eventos evitados por cada 100 participantes tratados. En el Mes 42, el tratamiento continuo con acoramidis redujo la mortalidad cardiovascular en un 45% en comparación con placebo-al cambio a acoramidis (p=0,0011).
Ac o ramidis, comercializado como Attruby® en Estados Unidos y BEYONTTRA® en Europa, Japón y el Reino Unido, ha recibido aprobación regulatoria con etiquetas que especifican una estabilización casi completa de la TTR.
BridgeBio Pharma (Nasdaq: BBIO)는 ATTRibute-CM 연구에서 아코라마디스가 경구 TTR 안정화제이며 ATTR-CM(트랜스트레틴 혈관형 아밀로이드 심근증) 치료에 신속한 효능을 보여주었다고 발표했습니다. 이 약물은 치료의 첫 달 안에 유의미한 심혈관 혜택을 보였다.
주요 발견으로는 30개월까지 심혈관 사망 또는 재입원 위험의 49% 감소(p<0.0001), 치료군 100명당 53건의 사건 회피가 있습니다. 42개월 차에서는 지속적 치료 시 대조군 대비 심혈관 사망 45% 감소가 나타났습니다(p=0.0011).
Acoramidis는 미국에서 Attruby®, 유럽·일본·영국에서는 BEYONTTRA®로 판매되며, 거의 완전한 TTR 안정화를 명시한 라벨과 함께 규제 승인을 받았습니다.
BridgeBio Pharma (Nasdaq: BBIO) a présenté des données révolutionnaires de l’étude ATTRibute-CM montrant que acoramidis, leur stabilisateur oral de la TTR, démontre une efficacité rapide dans le traitement de l’ATTR-CM (carpiopathie amiloïde transthyretine). Le médicament a montré des bénéfices cardiovasculaires significatifs dès le premier mois de traitement.
Les résultats clés incluent une réduction du risque de 49% de mortalité cardiovasculaire ou d’hospitalisations récurrentes jusqu’au mois 30 (p<0,0001), avec 53 événements évités pour 100 participants traités. Au mois 42, le traitement continu par acoramidis a réduit la mortalité cardiovasculaire de 45% comparé au passage du placebo à acoramidis (p=0,0011).
Acoramidis, commercialisé sous le nom Attruby® aux États-Unis et BEYONTTRA® en Europe, au Japon et au Royaume‑Uni, a reçu l’approbation réglementaire avec des étiquettes indiquant une stabilisation quasi complète de la TTR.
BridgeBio Pharma (Nasdaq: BBIO) präsentierte bahnbrechende Daten aus der ATTRibute-CM-Studie, die zeigen, dass acoramidis, ihr orales TTR-Stabilisator, eine rasche Wirksamkeit bei der Behandlung von ATTR-CM ( transthyretin-amyloid cardiomyopathy) demonstriert. Das Medikament zeigte signifikante kardiovaskuläre Vorteile bereits im ersten Monat.
Schlüsselbefunde beinhalten eine 49%-ige Risikoreduktion für kardiovaskuläre Sterblichkeit oder wiederholte Krankenhausaufenthalte bis Monat 30 (p<0,0001), mit 53 vermiedenen Ereignissen pro 100 behandelten Teilnehmern. Bis Monat 42 reduzierte eine kontinuierliche Behandlung mit Acoramidis die kardiovaskuläre Sterblichkeit um 45% im Vergleich zu Placebo-zu-Acoramidis-Umlauf (p=0,0011).
Acoramidis, in den USA unter dem Markennamen Attruby® und in Europa, Japan und dem Vereinigten Königreich unter BEYONTTRA® erhältlich, hat regulatorische Zulassung erhalten mit Etiketten, die eine nahezu vollständige TTR-Stabilisierung spezifizieren.
BridgeBio Pharma (ناسداك: BBIO) قدمت بيانات رائدة من دراسة ATTRibute-CM تُظهر أن acoramidis، مثبّت TTR فموي، يبيّن فاعلية سريعة في علاج ATTR-CM (اعتلال عضلة القلب بالأميليويد الترانسيريتين). أظهر الدواء فوائد قلبية وعائية كبيرة في الشهر الأول من العلاج.
تشمل النتائج الأساسية خفض مخاطر الوفيات القلبية الوعائية أو الاستشفاء المتكرر بنسبة 49% حتى الشهر 30 (p<0.0001)، مع تجنب 53 حدثًا لكل 100 مشارك مُعالج. عند الشهر 42، خفّض العلاج المستمر بـ acoramidis الوفيات القلبية الوعائية بمقدار 45% مقارنة بالدواء الوهمي-للانتقال إلى acoramidis (p=0.0011).
يُباع Acoramidis باسم Attruby® في الولايات المتحدة وباسم BEYONTTRA® في أوروبا واليابان والمملكة المتحدة، وقد حاز على موافقة تنظيمية مع ملصقات تحدد استقرار TTR شبه الكامل.
BridgeBio Pharma（纳斯达克：BBIO） 在 ATTRibute-CM 研究中公布了突破性数据，显示 acoramidis，其口服 TTR 稳定剂，在治疗 ATTR-CM（ transthyretin淀粉样心肌病）方面显示出快速的疗效。药物在治疗的
关键发现包括在第 30 个月前，心血管死亡率或再次住院风险下降 49%（p<0.0001），每百名受试者中有53 个事件被避免。在第 42 个月，持续使用 acoramidis 的治疗将心血管死亡率相较于安慰剂转为 acoramidis 的组降低了 45%（p=0.0011）。
Acoramidis 在美国以 Attruby® 为商标，在欧洲、日本和英国为 BEYONTTRA®，已获得监管批准，标签注明几乎完整的 TTR 稳定化。
- Significant 49% reduction in cardiovascular mortality/hospitalization risk through Month 30
- Early efficacy demonstrated within first month of treatment
- 53 cardiovascular events prevented per 100 treated patients
- 45% reduction in cardiovascular mortality at Month 42
- Already approved in major markets (US, EU, Japan, UK)
- Disease progression continues despite treatment, requiring ongoing monitoring
- Treatment efficacy varies between wild-type and variant ATTR-CM patients
Insights
Acoramidis shows rapid effectiveness against ATTR-CM, reducing cardiovascular events within just one month of treatment with sustained 49% risk reduction.
BridgeBio's acoramidis (Attruby®) demonstrated remarkably early clinical efficacy against transthyretin amyloid cardiomyopathy (ATTR-CM), with numerical reductions in cumulative cardiovascular events occurring within the first month of treatment. The ATTRibute-CM study revealed the drug provided a 49% hazard reduction (p<0.0001) in the cumulative risk of cardiovascular mortality or recurrent hospitalizations through Month 30.
The magnitude of benefit is substantial, with data showing 53 events avoided per 100 treated patients at Month 30. This suggests a powerful treatment effect that grows progressively over time. Further supporting the drug's efficacy, extended follow-up to Month 42 showed a 45% reduction in cardiovascular mortality comparing continuous treatment versus patients who switched from placebo.
The mechanism behind these benefits involves acoramidis acting as a near-complete (≥90%) TTR stabilizer, effectively halting the protein misfolding that drives amyloid deposition in cardiac tissue. This early impact has critical implications for clinical practice, reinforcing the urgency of early diagnosis and treatment initiation.
Additional findings demonstrate efficacy across both wild-type and variant ATTR-CM genotypes, highlighting the drug's versatility. The medication also mitigates rises in NT-proBNP levels (a heart failure biomarker) and shows favorable effects on cardiac conduction parameters, suggesting multifaceted cardiac benefits.
For ATTR-CM patients who face progressive heart failure with limited treatment options, these results represent a significant advancement in disease management. The rapid onset of action could potentially slow disease progression before irreversible cardiac damage occurs, changing the trajectory of this previously devastating disease.
- By Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo
- Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a
- The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (
PALO ALTO, Calif., Sept. 28, 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 study showing that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in patients with ATTR-CM. These data were presented in a Late Breaking Clinical Trials Oral Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2025 and simultaneously published in Journal of the American College of Cardiology. Acoramidis is a selective, small molecule, orally administered, near-complete (≥
“Acoramidis demonstrated early and sustained clinical efficacy on the totality of cumulative cardiovascular outcomes, where accrued events start to numerically diverge within the first month of treatment,” said Ahmad Masri, M.D., M.S. of Oregon Health & Science University. “As a practicing cardiologist, these findings are incredibly meaningful because it draws attention to the time-sensitive nature of transthyretin amyloidosis diagnosis and treatment initiation, where a safe and effective treatment such as acoramidis can potentially have an early effect on reducing patients' risk of cardiovascular hospitalizations and events.”
Details from the late breaking oral presentation, Effect of Acoramidis on Recurrent and Cumulative Cardiovascular Outcomes in ATTR-CM: Exploratory Analysis from ATTRibute-CM, presented by Dr. Masri included:
- At Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo
- Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a
49% hazard reduction (p<0.0001) - The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (
95% CI:29–79) - In addition to the late breaking oral presentation, a simultaneous publication in Journal of the American College of Cardiology, with the same title as the presentation, noted the same details and also concluded that at Month 42, CVM was reduced with continuous acoramidis versus placebo-to-acoramidis with a hazard reduction of
45% (p=0.0011)
In addition to the late breaking oral presentation and simultaneous publication of the cumulative cardiovascular outcomes data from ATTRibute-CM, one oral presentation and three poster sessions were shared on the open-label extension data from ATTRibute-CM and real-world evidence. These findings included:
- Continuous Acoramidis Treatment Significantly Reduced Risk of All-cause Mortality and Cardiovascular-related Hospitalization at Month 42, in Patients with Wild-type And Variant Transthyretin Amyloidosis Cardiomyopathy, shared in an oral presentation by Lily Stern, M.D. of Cedars-Sinai Heart Institute
- At Month 42, continuous acoramidis was associated with lower risk of all-cause mortality (ACM), first CVH, and ACM/first CVH vs placebo to acoramidis switch in both wild-type ATTR-CM and variant ATTR-CM, highlighting the importance of early and continuous acoramidis regardless of TTR genotype
- Acoramidis Mitigates the Rise in NT-proBNP Levels Observed with Placebo in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM, presented in a poster session by Nitasha Sarswat, M.D. of UChicago Medicine
- In the variant ATTR-CM subpopulation from ATTRibute-CM, acoramidis consistently mitigated the rise in N-terminal pro-B-type natriuretic peptide (NT-proBNP) observed in the placebo variant group, with effects starting at Month 3, and continuing through Month 30. Considering the higher risk posed by variant ATTR-CM, these findings are especially relevant in addressing the distinct medical needs of the variant ATTR-CM patient population
- Effect of Acoramidis on Cardiac Conduction Abnormalities in Transthyretin Amyloid Cardiomyopathy, presented in a poster session by Brett W. Sperry, M.D. of Saint Luke's Health System
- In ATTRibute-CM, acoramidis treatment was associated with numerically lower percentages of participants with worsening, prolonged PR or QRS intervals at Month 24 and Month 30, compared with placebo. These observations are consistent with the slowing of ATTR-CM disease progression previously reported with acoramidis
- State-Level Differences in Incidence of Transthyretin Amyloid Cardiomyopathy in United States Veterans Persist After Introduction of Disease-Modifying Therapy, presented in a poster session by Sandesh Dev, M.D. of Arizona State University
- The incidence of ATTR-CM in the U.S. Veteran population increased nationally in the setting of available treatment, possibly due to improved awareness in most states
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 is 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
BridgeBio Pharma (BridgeBio; NASDAQ:BBIO) 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 to have an early effect on reducing patients’ risk of cardiovascular hospitalizations and events, the timing of future data disclosures, and BridgeBio’s ongoing development pipeline, 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
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FAQ
What are the key clinical results for BridgeBio's (BBIO) acoramidis in ATTR-CM treatment?
How effective is acoramidis in reducing cardiovascular mortality in ATTR-CM patients?
Where is BridgeBio's (BBIO) acoramidis approved and under what names?
What type of drug is BBIO's acoramidis and how is it administered?
How does acoramidis affect NT-proBNP levels in variant ATTR-CM patients?
