BridgeBio presented additional data from an analysis of acoramidis studies

BridgeBio Pharma (BBIO) announced it presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology, or ESC, 2024. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of TTR. The data on change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis in the OLE study, were presented by Mathew Maurer, M.D. of Columbia University Irving Medical Center. In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its OLE, there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE. Based on the positive results from ATTRibute-CM, BridgeBio submitted a New Drug Application to the U.S. Food and Drug Administration, which has been accepted with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. BridgeBio has granted exclusive rights to Bayer (BAYRY) to commercialize acoramidis for ATTR-CM in Europe.