(RTTNews) - BridgeBio Pharma Inc. (BBIO), a commercial-stage biopharmaceutical company, on Monday announced new data from its Phase 3 ATTRibute-CM study of Acoramidis, demonstrating disease-modifying effects across clinical outcomes, biomarkers, and functional capacity in transthyretin amyloid cardiomyopathy.
The phase 3 ATTRibute-CM study formed the basis of FDA approval for Acoramidis.
Acoramidis, a transthyretin stabilizer, received FDA approval in November 2024 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.
According to the new data, there is an association between treatment-related serum transthyretin (sTTR), and a decrease in variable sTTR levels over time. Levels of sTTR are used as an early marker of disease progression, with higher achieved levels and lower variability associated with improved survival outcomes.
Patients treated with acoradimis also demonstrated a lower risk of outpatient worsening, with heart failure reduced by 41% versus treatment with placebo. Compared to tafamidis, acoradimis showed a decrease in cardiovascular hospitalizations by 34%, and a 28% hazard reduction in all-cause mortality. Both drugs had comparable safety profiles.
BBIO is currently trading at $66.10, down 1.91%.
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