dm+d

Unassigned

New Medicines

Stable coronary artery disease (CAD) and moderately decreased LVEF in adults undergoing CABG surgery

Information

New molecular entity
AstraZeneca
Moderna Therapeutics

Development and Regulatory status

None
Phase II Clinical Trials
None
Nov 21Following positive data from PIIa trial, company plans to move to further trials with AZD8601. Still PII in AZ pipeline. [3,5]

Category

mRNA therapy which encodes for VEGF-A production in vivo. VEGF-A leads to creation of more blood vessels and improved blood supply by stimulating the division of progenitor cells contributing to heart repair and regeneration. [2,3]
In 2014/15 there were 16,786 CABG operations compared to 14,527 in 2017/18 (a reduction of 13% in 4 years). [1]
Stable coronary artery disease (CAD) and moderately decreased LVEF in adults undergoing CABG surgery
Intracoronary

Trial or other data

Nov 21AZ and Moderna announced that AZD8601 met its primary endpoint of safety and tolerability in the PIIa EPICCURE trial (NCT03370887), a randomised, double-blinded, multi-centre, placebo-controlled trial in 11 pts undergoing elective coronary artery bypass (CABG) surgery. AZD8601 (3mg or 30mg) was injected into the myocardium of pts during the CABG procedure. Out of 11 pts, 7 received AZD8601 while 4 received placebo. Pts were observed for 6 months according to 3 efficacy endpoints, NT-proBNP, left ventricular ejection fraction (LVEF), and patient reported outcomes. The primary endpoint was safety and tolerability of AZD8601. There were no deaths, infections or treatment-related serious adverse events related to AZD8601. Exploratory efficacy endpoints for LVEF, NT-proBNP, and functional patient reported outcomes resulted in a positive trend for the treated group. [3,4]