BridgeBio presents additional outcomes data from Phase 3 ATTRibute-CM study

BridgeBio Pharma presented additional Phase 3 data from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM, at the American Heart Association 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. 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, was observed on the primary endpoint. 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. 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 to avoid a death or first CVH over 30 months was 7. 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.