Pivotal Preclinical Studies of Novel Infusible ECM for Treating Acute MI

Summary Heart failure post-myocardial infarction (MI) continues to be the leading cause of death in the U.S. Each year it is estimated that ~550K Americans will have a new MI, and ~200K will have a recurrent MI, leading to a large body of patients suffering from heart failure. These staggering statistics necessitate the development of new therapies for patients with ischemic cardiomyopathy. Tissue engineering and regenerative medicine strategies offer significant potential for the development of novel therapies to treat these patients. While cell therapies have been extensively studied for the treatment of MI and heart failure, meta-analyses of initial cell therapy trials suggest only a modest effect on cardiac function. More recently acellular biomaterials have shown great promise in providing similar or greater functional benefit without the complications associated with cell delivery. Injectable biomaterials that stimulate endogenous repair are an attractive alternative since potential therapies could still be delivered minimally invasively via catheter yet could be off the shelf and have significantly reduced costs compared to cell products. Ventrix is therefore focusing on cell-free regenerative medicine approaches. Ventrix has a history of success in developing injectable biomaterials for treating ischemic cardiomyopathy. Two previous NIH SBIRs resulted in an approved IND for VentriGel, an injectable, catheter-deliverable hydrogel derived from decellularized porcine myocardium. This led to a recent successful Phase 1 clinical trial in patients 60 days to 3 years post-MI. We recently developed a new Infusible ECM, for treating acute MI. We showed it can be delivered to an acute MI via intracoronary infusion and that it improves cardiac function in a rat acute MI model following simulated intracoronary delivery. In our previous studies, we optimized delivery and retention of Infusible ECM and demonstrated preliminary feasibility and efficacy in a porcine acute MI model. The studies proposed in this Phase II project are part of the final steps to initiate studying Infusible ECM in patients, and a key step in bringing a biomaterial product to market, which will be complementary to existing standard of care. This will be the first intracoronary infusible regenerative biomaterial product for treating acute MI patients.