AZD8601 Phase 2a EPICCURE Trial Shows All Treated Heart Failure Patients Achieve NT-proBNP Levels Below Heart Failure Threshold

November 17, 2021 /BioValleyBIOON/ --AstraZenecaAstraZeneca recently announced positive results from the Phase 2a EPICCURE study, showing that in heart failure (HF) patients,AZD8601 Met the Primary Endpoints of Safety and Tolerability。

AZD8601 is an mRNA encoding vascular endothelial growth factor (VEGF-A), currently being co-developed by AstraZeneca and Moderna. VEGF-A is a paracrine factor that plays a crucial role in the formation of new blood vessels. Additionally, it has been shown to stimulate progenitor cell division. Progenitor cells areStem CellsDescendants, when stimulated, will differentiate, thereby producing special cell types that contribute to heart repair and regeneration.

In the study, the researchersInject AZD8601 directly into the myocardium of patients undergoing elective coronary artery bypass grafting (CABG).In the study of 11 patients, 7 patients received AZD8601 injection treatment and 4 patients received placebo injections. All 11 patients were followed up for 6 months to evaluate the primary safety and exploratory efficacy endpoints.

Notably, this trial is the first clinical trial to directly inject naked mRNA into the hearts of patients undergoing elective CABG. The results showed,Compared with the placebo group, a positive trend was observed in the AZD8601 treatment group across three exploratory efficacy endpoints for heart failure.：Left ventricular ejection fraction (LVEF) increased, functional patient-reported outcomes improved, and NT-proBNP decreased (a biomarker measuring hormone levels, elevated in heart failure patients).. Particularly, at the 6-month follow-up after treatment,NT-proBNP Levels in All 7 Patients in the AZD8601 Treatment Group Below Heart Failure (HF) Threshold, whereas only one of the four patients in the placebo group showed improvement. In this study, there were no deaths or treatment-related serious adverse events, and no infections associated with AZD8601 treatment were observed.

Although no significant effect could be shown due to limited data, it provides AstraZeneca with the opportunity to advance AZD8601 into further trials. Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated, "During a heart attack, more than a billion heart cells can be lost. These early results suggest that mRNA therapy has the potential to stimulate VEGF-A production, offering repair and disease-modifying options for patients with heart failure and other ischemic vascular diseases."

Moderna CEO Stéphane Bancel stated, "mRNA is a compelling therapeutic approach because it can act locally and transiently while driving dose-dependent protein expression. The results announced today push new boundaries in the treatment of cardiovascular and other ischemic vascular diseases, addressing significant unmet needs to improve patients' lives."

Heart failure (HF) affects approximately 64 million people worldwide, with at least half of them having a reduced ejection fraction. It is a chronic condition, and half of the patients will...DiagnosisDeath occurs within 5 years. Ejection fraction (EF) measures the percentage of blood leaving the heart with each contraction; based on EF, heart failure (HF) is divided into two main categories: Heart Failure with Reduced Ejection Fraction (HFrEF) and Heart Failure with Preserved Ejection Fraction (HFpEF). HFrEF occurs when the left ventricular muscle cannot contract sufficiently, resulting in less oxygen-rich blood being pumped from the heart to the body. HF remains associated with men (prostate and bladder cancer) and women (Breast Cancer) As fatal as the most common cancers. Chronic heart failure is the leading cause of hospitalization for patients over 65, representing a significant clinical and economic burden.

mRNA is responsible for carrying genetic instructions transcribed from DNA, which are then translated by cells to produce proteins. Proteins are responsible for directing the biological functions of the body. Moderna's groundbreaking mRNA therapy aims to trigger cellular mechanisms to produce specific proteins. AZD8601 enables the delivery of mRNA instructions to stimulate the production of the VEGF-A protein.

AstraZeneca and Moderna have reached an exclusive agreement to discover, develop, and commercialize mRNA therapies for the treatment of severe cardiovascular, metabolic, and renal diseases as well as cancer. AstraZeneca has an unparalleled deep understanding of cardiovascular disease biology and the discovery and development of drugs in this field, while Moderna brings advanced mRNA technology and the ability to convert various mRNAs into therapeutic proteins. (Bioon.com)

Source of the original text:AZD8601 EPICCURE Phase II trial demonstrated safety and tolerability in patients with heart failure