BioCardia’s data safety monitoring board already warned that the phase 3 CardiAMP cell therapy heart failure trial was not going to make the primary endpoint. And so the California biotech is showcasing some other endpoints instead, hoping to persuade investors that the autologous cell therapy has a future.
CardiAMP was tested in 110 patients with advanced chronic heart failure, with mean follow-up at 20 months. The cell therapy involves delivering a patient’s bone marrow cells to the heart via a catheter-based procedure with the hope of stimulating the body’s natural healing response.
The primary endpoint was a three-pronged evaluation of the condition: all-cause death, nonfatal major adverse cardiac and cerebrovascular events (MACCE) and a six-minute walk distance test from baseline to 12 months. BioCardia revealed an interim look at the study at the Technology and Heart Failure Therapeutics 2024 annual meeting.
After 20 months, patients who received a dose of CardiAMP had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in nonfatal incidences of heart attacks, strokes and hospitalization due to heart failure. Patients also had a 5% lower rate of heart death equivalents at up to two years compared to control patients who received just heart failure medication.
BioCardia also said that CardiAMP was associated with “trends” toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction and improved NTproBNP, which is a marker of heart distress.
In a subgroup analysis that focused on patients with high NTproBNP at baseline, there was an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. This group also had a 17% lower rate of heart death equivalents at the two-year mark compared to the control group.
“While the trial’s data safety monitoring board determined that the study would not meet its composite primary endpoint that included six-minute walk distance per the trial design, the positive results for reduced heart death equivalents, reduced MACCE, and safety indicate potential for this therapy to improve outcomes for patients with advanced chronic heart failure,” said the trial’s co-principal investigator, Amish Raval, M.D., director of clinical cardiovascular research and professor of medicine at the University of Wisconsin-Madison.
BioCardia did not report updated results for the six-minute walk test nor any safety data.