BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure
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Insights
A recent trial has indicated that CardiAMP cell therapy may offer a substantial reduction in the risk of heart death equivalents and non-fatal major adverse cardiac and cerebrovascular events (MACCE) in patients with advanced chronic heart failure. Particularly noteworthy is the pronounced benefit observed in patients with elevated NTproBNP levels, a biomarker for heart failure severity. The 86% relative risk reduction in heart death equivalents among this subgroup suggests a potentially significant clinical benefit.
From a cardiological perspective, the enhanced heart function, as evidenced by improved left ventricular ejection fraction and the reduction in ventricular tachyarrhythmias, are encouraging signs of the therapy's potential impact on patient morbidity and mortality. However, it is important to consider the trial's inability to meet the composite primary endpoint, which included a six-minute walk distance, a common measure of functional status in heart failure patients. This discrepancy raises questions about the therapy's impact on patients' quality of life and functional capacity, which are crucial factors in the management of chronic heart failure.
The follow-on Phase III trial of CardiAMP cell therapy, specifically targeting a high-responding patient population with elevated NTproBNP, represents a strategic approach to validating the therapy's efficacy. This precision medicine angle—focusing on patients more likely to benefit from the treatment—could enhance the clinical relevance and cost-effectiveness of the therapy if it is approved.
Furthermore, the safety profile of the therapy, as indicated by the lack of treatment-emergent adverse events in the initial cohort of a separate study on allogeneic mesenchymal stem cell therapy, is a critical aspect. Safety data is a pivotal factor in FDA approval processes and can significantly influence market acceptance and insurance coverage.
The potential for CardiAMP cell therapy to reduce hospital readmission rates is an important economic consideration. Chronic heart failure is associated with high healthcare costs, primarily due to frequent hospitalizations. Therefore, therapies that can decrease the incidence of heart death equivalents and MACCE could lead to significant savings for healthcare systems.
However, the cost of cell therapies can be substantial and it is essential to balance these against the potential savings from reduced hospital admissions and improved patient outcomes. The long-term economic impact will depend on the therapy's pricing, reimbursement policies and the extent to which it can replace or reduce the need for other treatments, such as left ventricular assist devices or heart transplants.
- CardiAMP cell therapy-treated patients had
37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone - Large sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with
86% relative risk reduction in heart death equivalents and24% relative risk reduction in non-fatal MACCE - FDA-approved follow-on Phase III trial of high-responding patient population with elevated NTproBNP (CardiAMP HF II) has launched to validate positive interim results
SUNNYVALE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. The data was presented today by Amish Raval, MD, Director of Clinical Cardiovascular Research and Professor of Medicine at the University of Wisconsin-Madison at the Technology and Heart Failure Therapeutics (THT) 2024 annual meeting.
Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy while on maximal medical therapy had a
In a subgroup analysis of patients with elevated NTproBNP at baseline – encompassing
“These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator Dr. Raval. “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. Despite improvements with current medications and devices, heart failure remains at epidemic proportions and we now have an exciting opportunity for a therapy to improve important, objective outcomes, such as mortality and hospital re-admissions rates. I am excited to be part of a terrific team to validate the promise of this therapy in this high responder group in the follow-on trial that is now FDA-approved and soon to treat its first patient.”
“We thank the FDA for its speedy review and approval of the important follow-on Phase III trial. We are encouraged by the totality of today’s results and anticipate that both the final 24-month data analysis and follow-on trial outcomes would be consistent with this highly positive data,” said BioCardia CEO Peter Altman.
Also at the THT scientific meeting, first enrollment for the dose escalation safety phase of BioCardia’s Phase I/II study of the CardiALLO™ allogeneic mesenchymal stem cell (MSC) therapy in heart failure patients was reported. The cohort receiving the lowest dose of 20 million cells has been initiated with no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The first author of the study is R. David Anderson, MD, Professor of Medicine at the University of Florida at Gainesville. Following completion of the dose escalation safety phase of the study, a Phase II randomized double-blind controlled study is planned to assess efficacy.
About BioCardia’s CardiAMP Autologous Cell Therapy Program*
Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP HF trial is supported by the Maryland Stem Cell Research Fund and has reimbursement from the Centers for Medicare and Medicaid Services (CMS) for both treatment and control procedures. The CardiAMP HF II trial is expected to similarly secure CMS reimbursement.
About BioCardia’s CardiALLO Allogeneic Cell Therapy Program*
CardiALLO allogeneic cell therapy provides an “off the shelf” mesenchymal stem cell therapy typically derived from younger donors. These cells are immunomodulatory, with the potential to impact inflammatory processes in heart failure and have been shown to release multiple critical angiogenic factors that can enhance microvascular function and capillary networks in ischemic tissue. CardiALLO therapy for heart failure uses BioCardia’s new MSC manufacturing process, which builds on the experience of three completed co-sponsored MSC clinical trials encompassing 84 treated patients in the same indication with the same delivery platform.
*CardiAMP and CardiALLO therapies are considered investigational and limited by U.S. law to investigational use only.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system, as well as preclinical and clinical development services for biotherapeutic delivery to the heart.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, whether the final 24-month analysis and follow-on trial outcomes would be consistent with the interim results presented here as expected, whether CardiAMP HF II receives CMS reimbursement as expected, whether CardiAMP HF II validates the results of the interim data from CardiAMP HF, and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
MEDIA CONTACT:
Michelle McAdam
michelle@chronic-comm.com, 310-902-1274
INVESTOR CONTACT:
David McClung, Chief Financial Officer
investors@biocardia.com, 650-226-0120
FAQ
What are the key results of the Phase III trial of CardiAMP cell therapy by BioCardia, Inc. (BCDA)?
What is the follow-on Phase III trial launched by BioCardia, Inc. (BCDA)?
What was reported about the CardiALLO MSC therapy in the PR?
