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November 16, 2021updated 11 Jul 2022 2:19pm

Moderna and AstraZeneca therapy meets primary goal in Phase IIa CABG trial

All subjects who received AZD8601 were found to have NT-proBNP levels below the heart failure limit after a six-month follow-up.

Moderna and AstraZeneca have reported that their experimental therapy, AZD8601, met the primary goal of safety and tolerability in the Phase IIa EPICCURE clinical trial in patients undergoing coronary artery bypass grafting (CABG).

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Developed jointly by the companies, AZD8601 is a messenger ribonucleic acid (mRNA) treatment encoding for vascular endothelial growth factor-A (VEGF-A).

Carried out by AstraZeneca, the placebo-controlled, randomised, double-blind, multicentre, six-month trial analysed the safety, tolerability and exploratory efficacy of epicardial doses of AZD8601.

A total of 11 individuals with stable coronary artery disease and moderately decreased left ventricular ejection fraction (LVEF) undergoing CABG surgery was part of the trial.

Seven of them were given AZD8601 directly into the myocardium while four others received a placebo.

Numerical trends were reported in the three exploratory efficacy goals of the trial: LVEF; NT-proBNP; and functional subject-reported outcomes versus placebo.

A biomarker, NT-proBNP assesses the level of a hormone and is found to be high in heart failure patients.

After a six-month follow-up, all seven subjects in the AZD8601 arm were found to have NT-proBNP levels below the heart failure limit as against one in the placebo arm.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.”

AstraZeneca and Moderna collaborated in 2013 to develop and market mRNA therapies to treat various cardiovascular, metabolic, and renal diseases.

Last month, Moderna dosed the first patient in the Phase III CMVictory trial of its cytomegalovirus vaccine candidate, mRNA-1647.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

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by Suvoda
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