“`html
BridgeBio Pharma (Nasdaq: BBIO) is making waves in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) with its oral TTR stabilizer, acoramidis. New data from the ATTRibute-CM study highlights the drug’s rapid efficacy, demonstrating significant cardiovascular benefits within the first month of treatment.
The pivotal ATTRibute-CM study showed a 49% hazard reduction in the composite endpoint of cardiovascular mortality or recurrent hospitalizations through Month 30 (p53 events avoided per 100 treated participants). Extended follow-up to Month 42 revealed continuous acoramidis treatment reduced cardiovascular mortality by 45% compared to patients who switched from placebo to acoramidis (p=0.0011).
Acoramidis, commercially available as Attruby® in the US and BEYONTTRA® in Europe, Japan, and the UK, boasts regulatory approval with labels confirming near-complete TTR stabilization, a key factor in its mechanism of action.
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 (p53 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 (p53 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).
Acoramidis, 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(p53건의 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 (p53 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 (p53 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 (pتجنب 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。药物在治疗的首月即显示出显著的心血管获益。
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%（p53 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。
Positive
- 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)
Negative
- 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
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.
09/28/2025 – 11:15 AM
– 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 49% hazard reduction (p
– 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)
Acoramidis is a selective, small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.
FAQ
What are the key clinical results for BridgeBio’s (BBIO) acoramidis in ATTR-CM treatment?
Acoramidis demonstrated a 49% reduction in cardiovascular events through Month 30 and prevented 53 events per 100 treated patients. The drug showed benefits within the first month of treatment.
How effective is acoramidis in reducing cardiovascular mortality in ATTR-CM patients?
At Month 42, acoramidis reduced cardiovascular mortality by 45% compared to placebo-to-acoramidis switch (p=0.0011).
Where is BridgeBio’s (BBIO) acoramidis approved and under what names?
Acoramidis is approved as Attruby® in the US and as BEYONTTRA® in the European Union, Japan, and the United Kingdom.
What type of drug is BBIO’s acoramidis and how is it administered?
Acoramidis is a selective, small molecule, orally administered TTR stabilizer that achieves near-complete (≥90%) transthyretin stabilization.
How does acoramidis affect NT-proBNP levels in variant ATTR-CM patients?
Acoramidis mitigates the rise in NT-proBNP levels observed in variant ATTR-CM patients, with effects starting at Month 3 and continuing through Month 30.
“`
Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/10064.html
