BioCardia shares fell over 20% in premarket trade on Tuesday after it revealed that its Phase 3 trial of CardiAMP cell therapy for heart failure was unlikely to meet its three-tiered primary efficacy endpoint based on interim trial results.
CardiAMP cell therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. It has been granted Breakthrough Designation from the Food and Drug Administration (FDA) for the treatment of heart failure of reduced ejection fraction, BioCardia highlighted.
“Although the trial interim efficacy results show that the trial is unlikely to achieve its primary endpoint at one year, these results show that, while not statistically significant, there were trends towards patient benefits for the CardiAMP cell therapy over the course of the study, including a reduction in all-cause death, including heart death equivalents and major adverse cardiac events major adverse cardiac events (MACCE),” co-national principal investigator Dr. Amish Raval said in a statement.
The aggregate outcomes data also shows promising low rates of adverse outcomes for a cohort of more than 100 patients with heart failure of reduced ejection fraction due to ischemic heart disease, pointed out co-national principal investigator Dr. Carl Pepine.
“Furthermore, the study is the first to demonstrate that it is feasible to ‘personalize’ therapy using a novel bone marrow cell population analysis, process the cells at the bedside, and safely administer them by a trans myocardial injection system,” Dr. Pepine said.
BioCardia CEO Peter Altman said the company was actively engaged with identifying patients who responded the most to the cell therapy and considering other learnings to inform this program and its two other ongoing clinical programs.
Shares of the Sunnyvale, California-based company fell 20.4% to US$0.62 before the opening bell on Tuesday.
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