BridgeBio Plans NDA for Cardiomyopathy Drug

BridgeBio Pharma says it plans to file an NDA by the end of the year after reporting “positive results” from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM.

“ATTR-CM is an increasingly recognized cause of heart failure,” a company release says. The results from BridgeBio’s ATTRibute-CM trial showed an "81% on-treatment survival rate (versus a 74% survival rate on placebo), which begins to approach actuarial models of life expectancy absent ATTR-CM (85% in this population as has been documented),” it says. “The absolute risk reduction was 6.43% and the relative risk reduction was 25%.” Additionally, it says the study demonstrated a statistically significant relative risk reduction of 50% on frequency of cardiovascular-related hospitalization.

Bridgebio also says that no safety signals that have any “potential clinical concern” were identified.