BridgeBio: Positive Results from Phase 3 Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

  ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM) and frequency of cardiovascular-related hospitalization (CVH)), with a Win Ratio of 1.8 (p<0.0001)

- Acoramidis demonstrated an observed 30-month survival rate of 80.7% in the treatment arm of ATTRibute-CM; recent data from the U.S. Social Security Administration estimated 30-month survival at 85% in an age-matched cohort of the general population; similarly, the annualized CVH rate of 0.29 in the treatment arm can be viewed in the context of the annual overall hospitalization rate of 0.26 in the U.S. Medicare population

- Acoramidis is the only intervention to demonstrate cardiovascular outcomes benefit in a prospective clinical trial in the contemporary ATTR-CM population to the Company's knowledge

- Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified

-   BridgeBio has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and intends to submit marketing authorization applications to additional regulatory bodies in 2024

https://www.globenewswire.com/news-release/2024/01/10/2807550/0/en/BridgeBio-Pharma-Announces-Publication-of-Positive-Results-from-Phase-3-ATTRibute-CM-Study-of-Acoramidis-for-Patients-with-Transthyretin-Amyloid-Cardiomyopathy-ATTR-CM-in-the-New-E.html