BridgeBio Pharma presented new Phase 3 ATTRibute-CM data showing acoramidis improved heart failure outcomes, biomarkers, and survival-related measures in transthyretin amyloid cardiomyopathy (ATTR-CM).
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
BridgeBio Pharma presented new late‑breaking Phase 3 ATTRibute‑CM data (NCT03860935) at Heart Failure 2026, further strengthening evidence for acoramidis in transthyretin amyloid cardiomyopathy (ATTR‑CM). The investigational transthyretin (TTR) stabilizer demonstrated consistent disease‑modifying benefits across pre‑specified endpoints including survival, heart failure progression, biomarkers, and patient‑reported outcomes.
Mechanistic Insights
Senthil Selvaraj, M.D. (Duke University School of Medicine) reported that acoramidis rapidly increased serum transthyretin (sTTR) levels and maintained them through Month 30, while significantly reducing sTTR variability versus placebo. Both higher achieved sTTR levels and lower variability were independently associated with reduced all‑cause mortality. Participants who achieved higher and more stable sTTR levels experienced the greatest survival benefit, whereas greater variability correlated with adverse ATTR‑CM features. Reduced sTTR variability mediated ~20% of acoramidis’ survival benefit, suggesting that both stability and magnitude of sTTR contribute to its disease‑modifying effect.
Heart Failure Outcomes
Marianna Fontana, M.D. (University College London) presented data showing that acoramidis reduced the risk of outpatient worsening heart failure by 41% compared with placebo, with Kaplan‑Meier curve separation observed within 30 days and sustained through Month 30. Outpatient worsening heart failure was identified as a strong predictor of mortality and cardiovascular hospitalizations. Even after adjustment for worsening heart failure events, acoramidis continued to demonstrate a 41% reduction in mortality and recurrent cardiovascular hospitalizations.
Indirect Comparison with Tafamidis
Emer Joyce, M.D., Ph.D. (Mater Misericordiae University Hospital) presented the first anchored matching‑adjusted indirect comparison of acoramidis versus tafamidis. Results showed a statistically significant 34% reduction in cardiovascular hospitalizations with acoramidis, alongside a favorable 28% reduction trend in all‑cause mortality. Safety profiles were reported as comparable. Investigators noted that indirect comparisons have inherent limitations, but the findings suggest potential differentiation between therapies.
Biomarkers and Quality of Life
Poster presentations highlighted broader benefits across biomarkers and patient‑reported outcomes. Acoramidis consistently attenuated NT‑proBNP increases across all patient subgroups, including advanced disease, and demonstrated sustained preservation of health status as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ‑OS). Patients receiving acoramidis were significantly more likely to maintain or improve health status over 30 months compared with placebo.
Regulatory Status
Acoramidis is marketed as Attruby in the United States and as BEYONTTRA in several international markets, with approvals from the European Medicines Agency, Japan’s PMDA, Swissmedic, the UK MHRA, and Brazil’s ANVISA. BridgeBio indicated that further long‑term and subgroup analyses will be presented at upcoming cardiology and amyloidosis meetings.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.