BridgeBio Pharma Inc (NASDAQ:BBIO) announced the presentation of detailed results from its Phase 3 ATTRibute-CM study of acoramidis for ATTR-CM at the European Society of Cardiology Congress 2023. 

Transthyretin amyloidosis (ATTR-CM) is a buildup of faulty proteins (fibrils) on the heart or nerves, making the heart weak to pump blood.

In July, BridgeBio announced topline results from ATTRibute-CM.

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 prioritizing in order- across all-cause mortality (ACM), then the frequency of cardiovascular-related hospitalizations (CVH), then change from baseline in NT-proBNP, then change from baseline in 6-minute walk distance (6MWD). 

An 81% survival rate on acoramidis (versus a 74% survival rate on placebo) for an absolute risk reduction of 6.4% and a relative risk reduction of 25%, despite a ~50% higher rate of tafamidis use on the placebo arm relative to the treatment arm.

Overall, 79% of deaths in the study were cardiovascular (CV), and the results for CV-related mortality were consistent with what was observed on ACM.

A highly statistically significant relative risk reduction of 50% (p<0.0001) on the frequency of CVH

A highly statistically significant treatment effect (p<0.0001 in each case) at 30 months on change from baseline in each of NT-proBNP, KCCQ, and 6MWD.

Serum TTR was promptly and consistently elevated throughout the study in patients receiving acoramidis.

Acoramidis was generally well-tolerated with no safety findings of potential clinical concern.

The Company intends to submit its marketing application to the FDA before the end of 2023. Acoramidis has intellectual property protection out to at least 2039.

Price Action: BBIO shares are down 4.65% at $28.29 on the last check Monday.