BioCardia announces FDA approval of CardiAMP Heart Failure II protocol

BioCardia announced the Food and Drug Administration, FDA, approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. BioCardia announces that the Food and Drug Administration, FDA, has approved its proposed CardiAMP Heart Failure II study protocol. The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024. In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro B-type natriuretic peptide levels consistent as demarcating heart failure at screening-baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events. Further, all clinical outcome measures evaluated at follow-up for this interim subset favored cell therapy over guideline directed medical therapy, including having improved quality-of-life as measured using the Minnesota Living with Heart Failure Questionnaire, reduced NT-proBNP levels, greater walk distance as measured using the 6-minute walk distance test, and improved cardiac measures such as left ventricular ejection fraction and left ventricular end systolic and end diastolic volumes. Statistical significance was noted for both the reduced heart death equivalents measure and the improved quality of life measure. The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The proposed primary efficacy endpoint is also modified from that in the currently ongoing study. The CardiAMP Heart Failure II endpoint is a similar hierarchical composite assessment but consists of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months.