Benzinga | Dec 27, 2021 07:01AM EST

BridgeBio Pharma Reports Month 12 Results From Phase 3 ATTRibute-CM Study Did Not Meet Its Primary Endpoint

- ATTRibute-CM did not meet its primary endpoint at Month 12. Mean observed six-minute walk distance (6MWD) decline for the acoramidis and placebo arms were 9 meters and 7 meters, respectively. Both declines are similar to healthy elderly adults and less than prior untreated ATTR-CM cohorts



- The company observed improvements at Month 12 on the Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS, nominal p < 0.05), a quality-of-life measurement, N-terminal pro BNP (NT-proBNP, median +0.6% vs. +24.3%, nominal p < 0.05), a cardiac biomarker, and serum TTR concentration (mean +38.5% vs. -0.7%, nominal p < 0.01), a measure of TTR stabilization



- Acoramidis was generally well-tolerated with no safety signals of clinical concern identified. 27% fewer treatment emergent adverse events (AEs) leading to death occurred in participants receiving acoramidis than in participants receiving placebo (4.5% vs. 6.2%)



- The ATTRibute-CM independent data monitoring committee recommends continuing the study based on unblinded data reviews



- BridgeBio is fully funded through the completion of ATTRibute-CM and expects to realize at least four other clinical-stage pipeline catalysts beyond acoramidis in 2022



- BridgeBio to host investor call on December 27, 2021 at 8:00 AM ET