BridgeBio Shares Data On Serum TTR Increase When Switching Participants From Placebo And Tafamidis To Acoramidis In ATTRibute-CM And Its Open-Label Extension; Showed A 42% Reduction In Composite CVH And ACM, And A 50% Reduction In The Cumulative Frequency Of CVH Events Relative To Placebo At Month 30

Author: Benzinga Newsdesk | August 30, 2024 10:54am

- In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum transthyretin (TTR) at Month 1 of the OLE (n=21) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18)

 

- Increased serum TTR at Day 28 of ATTRibute-CM was correlated with reduced risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH) in transthyretin amyloid cardiomyopathy (ATTR-CM)

- Greater stabilization has been shown to improve clinical outcomes for patients, and in ATTRibute-CM, acoramidis, a near-complete stabilizer of TTR, demonstrated a significant impact on mortality, hospitalizations, and quality of life including:

-An early and sustained improvement relative to placebo in time to first event (CVH or ACM) starting at Month 3

-A 42% reduction in composite CVH and ACM events relative to placebo at Month 30

-A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30

PALO ALTO, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases, presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology (ESC) 2024. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of TTR.

The data on change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis in the OLE study, were presented by Mathew Maurer, M.D. of Columbia University Irving Medical Center. In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its OLE, there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE (n=21, p=0.01) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18, p=0.01).

TTR plays an important role in the body transporting thyroxine and vitamin A, and higher TTR levels are associated with less heart failure and better survival. BridgeBio previously shared results demonstrating that acoramidis treatment resulted in increased serum TTR levels by Day 28 that were sustained and were correlated with a reduced risk of ACM, CVM, and CVH in ATTR-CM participants through Month 30. This includes the following results:

• For every 5mg/dL increase in serum TTR level at Day 28 after treatment initiation, the risk of death through Month 30 was reduced by 30.9% (by the logistic model) and 26.1% (by the Cox proportional hazards model), showing a statistically significant correlation between increasing serum TTR and decreasing risk of death
• For each 1 mg/dL, increase in serum TTR on Day 28 after treatment initiation, there was a 5.5% risk reduction in cardiovascular death observed through Month 30
• For each 1 mg/dL, increase in serum TTR at Day 28 after treatment initiation was associated with a 4.7% lower risk of a first cardiovascular hospitalization over 30 months

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