Moderna Inc. (NASDAQ: MRNA) has announced positive results from the Phase 2 (EPICCURE) study led by AstraZeneca. The study is evaluating mRNA Therapeutics use that encodes for vascular endothelial growth factor-A in patients under coronary artery bypass grafting. The data from the study was presented at the American Heart Association Scientific Session 2021 Conference.
Study evaluated AZD8601’s tolerability and safety
The primary outcome of the Phase 2 study was AZD8601’s safety and tolerability. Seven of the 11 patients in the trial were given AZD8601 VEGF-A mRNA injections, while the other four were given placebo injections. Endpoints in the heart failure efficacy domains, such as patient-reported outcomes and increased left ventricular ejection fraction (LVEF), showed numerical trends when compared to placebo. Furthermore, at six months follow-up, all seven patients treated with AZD8601 had NT-proBNP levels below the HF limit, compared to one of four patients that received the placebo.
Moderna CEO Stephane Bancel said, “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. 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.”
mRNA therapeutics have the potential of eliciting VEGF-A production
AstraZeneca’s EVP Biopharmaceuticals R&D Mene Pangalos said, “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.”
AZD8601 is a locally delivered, experimental mRNA treatment that encodes for VEGF-A. EPICCURE is a 6-month, multicenter, randomized, placebo-controlled, double-blind, Phase 2a clinical trial evaluating the safety, tolerability, and experimental efficacy of AZD8601 epicardial injections in patients with moderately decreased LVEF and stable coronary artery disease that are undergoing CABG surgery.