BridgeBio Pharma, Inc. (NASDAQ: BBIO) on Sunday presented data from the ATTRibute-CM study.
The study showed that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in transthyretin amyloid cardiomyopathy (ATTR-CM) patients.
ATTR-CM is characterized by a buildup of faulty proteins (fibrils) in the heart or nerves. It can cause cardiomyopathy and heart failure.
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Acoramidis is approved as Attruby by the FDA and is approved as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and the U.K. Medicines and Healthcare Products Regulatory Agency, with all labels specifying near-complete stabilization of TTR protein.
These data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2025 and published in the Journal of the American College of Cardiology.
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.
The difference in cumulative events increased progressively, with results at Month 30 showing 53 events were avoided per 100 treated participants.
The publication in the Journal of the American College of Cardiology also concluded that at Month 42, CVM was reduced with continuous acoramidis versus placebo-to-acoramidis with a hazard reduction of 45%.
Additional findings included:
At Month 42, continuous acoramidis was associated with a 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.
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.
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.
Price Action: BBIO stock was trading higher by 2.93% to $51.52 at last check Monday.
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