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Moderna Announces Positive Data from Phase 2 Study of mRNA VEGF-A Therapeutic in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Phase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared
About this update from Moderna, Inc.
[{"type":"text","content":"\nPhase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in LVEF and patient reported outcomes\n\nResults support further investigation of AZD8601 for efficacy and safety in future larger studies\n\nAZD8601 is being co-developed with AstraZeneca\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced positive data from the AstraZeneca-led Phase 2 (EPICCURE) study evaluating the use of an mRNA therapeutic that encodes for vascular endothelial growth factor-A (VEGF-A) (AZD8601) in patients undergoing coronary artery bypass grafting (CABG). These data were presented today at the American Heart Association’s Scientific Sessions 2021 annual meeting.\n\nThe Phase 2 study met the primary endpoint of safety and tolerability of AZD8601. In the study of 11 patients, seven were treated with AZD8601 VEGF-A mRNA and four received placebo injections. Numerical trends were observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in left ventricular ejection fraction (LVEF) and patient reported outcomes. In addition, all seven patients treated with AZD8601 had NT-proBNP levels below heart failure (HF) limit at 6 months follow-up compared to one of four patients treated with placebo.\n\n“mRNA is a compelling therapeutic modality because of its ability to act locally and transiently, while driving dose-dependent protein expression. We thank AstraZeneca for their partnership and collaboration, which began in 2013, in advancing this program,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The results presented today are a result of pushing new boundaries in the treatment of cardiovascular and other ischemic vascular diseases to address serious unmet needs with the goal of improving patients’ lives.”\n\n“Over one billion heart cells can be lost during a heart attack. These early results indicate the potential of mRNA therapeutics in stimulating VEGF-A production to provide reparative and disease-modifying options for patients with heart failure and other ischemic vascular diseases,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, A...