BBIO - BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) | Benzinga
- As previously announced, the primary endpoint (a hierarchical analysis inclusive of all-cause mortality and frequency of cardiovascular-related hospitalization) was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001)
- The placebo and acoramidis time-to-first event Kaplan-Meier (K-M) curves for a composite of all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH) separated beginning at Month 3, representing the most rapid & sustained clinical benefit on the composite endpoint of ACM and CVH in ATTR-CM patients through Month 30 (Hazard Ratio = 0.645) to the Company's knowledge
- Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified
- 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
PALO ALTO, Calif., Nov. 12, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), 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 ...