BridgeBio Pharma Presents Updated Results from Phase 2 Open-label Extension Stud… – Press Release


– NT-proBNP, a biomarker of cardiac failure and independent predictor of mortality in ATTR-CM patients, was stable or improving throughout the study. At Month 30, median change from baseline in NT-proBNP was -437 pg/mL with 68% of participants observing NT-proBNP levels below their baseline

– Serum TTR levels were sustainably increased from baseline, with mean concentration rising from 21.55 mg/dL at baseline to 30.06 mg/dL at Month 30 (+41%)

– Acoramidis remained generally well-tolerated with no safety signals of clinical concern identified

– Topline data from ongoing Phase 3 trial of acoramidis in ATTR-CM (ATTRibute-CM) are expected in mid-2023

PALO ALTO, Calif., April 03, 2022 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. BBIO (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in patients with symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The results were featured in an oral presentation at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place in Washington, D.C. on April 2 – 4, 2022.

An interim analysis of the ongoing Phase 2 OLE study was completed based on available data through August 31, 2021. This corresponds to a median of 38 months since Phase 2 enrollment in the first half of 2018 and 35 months of continuous acoramidis treatment in the OLE. Acoramidis was generally well-tolerated and resulted in sustained, near-complete TTR stabilization as measured by established ex vivo assays and increased serum TTR levels. Median N-terminal Pro-brain natriuretic peptide (NT-ProBNP) was stable or improving in trial participants throughout the OLE. In ATTR-CM patients, NT-ProBNP concentrations are strongly correlated with mortality and typically increase progressively in untreated patients.1 The Phase 2 OLE data continue to suggest long-term…