News | Pharmaceuticals | November 21, 2023

BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

The company intends to file a New Drug Application (NDA) for acoramidis with the U.S. Food and Drug Administration (FDA) by end of 2023 


November 21, 2023 — BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today presented additional Phase 3 data from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM, at the American Heart Association (AHA) Scientific Sessions 2023. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). In July, BridgeBio announced positive topline results from ATTRibute-CM, and in August, BridgeBio presented detailed positive results at the European Society of Cardiology Congress 2023. BridgeBio will host an investor call on Sunday, November 12 at 11:15 am ET to discuss these results. 

“The positive results of the ATTRibute-CM study demonstrate that acoramidis improved clinical outcomes for ATTR-CM patients, even in the contemporary care setting. The early and sustained benefit on survival and cardiovascular-related hospitalization is remarkable and builds evidence towards the therapeutic hypothesis that near-complete TTR stabilization may improve clinical outcomes for ATTR-CM patients,” said Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina, and co-chair of the ATTRibute-CM Steering Committee. 

Improved clinical outcomes from the ATTRibute-CM study at Month 30 included: 

  • A highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001), was observed on the primary endpoint (a hierarchical analysis using the Finkelstein-Schoenfeld test prioritizing in order: ACM, then frequency of CVH, then change from baseline in NT-proBNP, then change from baseline in 6MWD) 
  • The K-M composite ACM and CVH Time-to-First Event curves for the treatment and placebo arms separated early, beginning at Month 3, and continued to diverge steadily through Month 30 with a Hazard Ratio of 0.645 (p=0.0008) 
    • This represents the most rapid clinical benefit on the composite endpoint of ACM and CVH outcomes in ATTR-CM to the Company’s knowledge 
    • The Number Needed to Treat (NNT) to avoid a death or first CVH over 30 months was 7 

“The results of the current analyses continue to build our confidence that acoramidis has the potential to provide important clinical benefits over current therapeutic options,” said Jonathan Fox, M.D., Ph.D., President, and Chief Medical Officer of BridgeBio Cardiorenal. “In addition to the early benefit on cardiovascular clinical outcomes, we observed an overall 30-month survival in the active treatment arm of ATTRibute-CM of 81%, which should be viewed in the context of the approximately 85% survival rate reported by the U.S. Social Security Administration in an age-matched cohort of the general population. Similarly, we observe that our annualized CV-related hospitalization rate of 0.29 in the acoramidis arm should be viewed in the context of the 0.26 overall hospitalization rate reported by the U.S. Department of Health and Human Services for the general Medicare population.” 

The Company intends to submit an NDA for acoramidis to the U.S. FDA before the end of 2023, with regulatory filings in additional markets to follow in 2024. Acoramidis is estimated to have intellectual property protection out to at least 2039. 

For more information: https://bridgebio.com/ 


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