BridgeBio Announces Positive Results for Heart Disease Drug
BridgeBio Pharma, Inc., (Nasdaq: BBIO) has reported positive results from its Phase 3 study of acoramidis in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a cardiac condition that is an increasingly recognized cause of heart failure.
BridgeBio intends to file a New Drug Application (NDA) with the FDA by the end of 2023, with regulatory filings in additional markets to follow in 2024. The company’s share rose by more than 75% following the news.
Highlights
BridgeBio’s trial demonstrated a highly statistically significant improvement in the primary endpoint and an 81% on-treatment survival rate (versus a 74% survival rate on placebo).
Dr. Daniel Judge, Professor of Medicine and Cardiology at the Medical University of South Carolina, and Co-Chair of the ATTRibute-CM Steering Committee, said, “The consistent and clinically meaningful benefits on survival, hospitalization, and additional measures of illness severity are truly remarkable.”
Prior preclinical and clinical studies have shown that acoramidis demonstrates approximately twice the stabilization of already-marketed stabilizers. Acoramidis has intellectual property protection out to at least 2039.
About BridgeBio
BridgeBio Pharma, Inc. is a commercial-stage biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.
