BridgeBio Pharma Presents Additional Data and Analyses from its Phase 3 ATTRibute-CM Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at ESC-HF, Including That Acoramidis Treatment Significantly Reduced All-Cause Mortality in a Pre-specified Se...

BridgeBio Pharma Presents Additional Data and Analyses from its Phase 3 ATTRibute-CM Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at ESC-HF, Including That Acoramidis Treatment Significantly Reduced All-Cause Mortality in a Pre-specified Sensitivity Analysis of the Entire Study Population

- In a pre-specified Cochran-Mantel-Haenszel sensitivity analysis applied to the entire intention-to-treat (ITT) population of the study (N=632), acoramidis significantly reduced all-cause mortality (p=0.04), with no safety signals of potential clinical concern

- Among ATTRibute-CM participants enrolled with Stage 4 chronic kidney disease (CKD) (N=21), acoramidis treatment was associated with proportionally fewer deaths compared with placebo, with no safety signals of potential clinical concern

- At Month 30 of the ATTRibute-CM study, acoramidis treatment resulted in a statistically significant and clinically important reduction in the progressive decline in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool, EQ-5D-5L

- Acoramidis treatment also reduced the decline in health status and quality of life as shown by statistically significant and clinically meaningful benefits in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, and supported by numerical and consistent benefits in individual KCCQ domains

- In ATTRibute-CM, acoramidis significantly improved NT-proBNP indices that can be a signal of ATTR-CM disease progression and be predictive of subsequent mortality risk

PALO ALTO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced positive results of four new analyses from its Phase 3 ATTRibute-CM study of acoramidis in ATTR-CM at the European Society of Cardiology (ESC) Heart Failure Congress 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 presented at ESC Heart Failure included a sub-analysis comparing acoramidis to placebo in Stage 4 CKD and results from a pre-specified ITT sensitivity analysis shared by Steen Hvitfeldt Poulsen, M.D., Ph.D., D.M.Sc. of the Aarhus University Hospital, DK. Key results included:

• In a pre-specified sensitivity analysis applied to the entire ITT population (N=632), acoramidis significantly reduced all-cause mortality (ACM) as assessed by the Cochran-Mantel-Haenszel (CMH) test (p=0.04)
• In high-risk participants with Stage 4 CKD (N=21), acoramidis treatment was associated with 25% relative risk reduction in deaths at Month 30 versus placebo, consistent with the observations in the modified intention-to-treat (mITT) population (N=611)
• No safety signals of potential clinical concern were identified

“ATTRibute-CM breaks new ground studying the efficacy and safety of acoramidis, a next-generation TTR stabilizer, as the only ATTR-CM outcomes trial to include patients with eGFR