BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial

SUNNYVALE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP Cell Therapy for Heart Failure (CardiAMP HF, clinicaltrials.gov Identifier: NCT02438306), for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction (HFrEF).

The external review both confirmed the quality and appropriateness of the work by the Statistical Data Analysis Center at the University of Wisconsin and the DSMB in their review and recommendation. In order to enhance understanding of our heart failure program, BioCardia has taken steps, previously reviewed by the DSMB, to unblind itself to the interim results of the study and was provided a copy of the closed session study report presented to the DSMB for review.

The interim efficacy review by the DSMB did not include the final results of the study but is an analysis of the data as part of the adaptive statistical analysis plan. This review was based on the three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis of 12-month data, whose composite score comprises the primary efficacy endpoint of the CardiAMP HF study.

1. For the first-tier, all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement at 12 months there were 5.6% of CardiAMP treatment patients versus 5.3% for the control group (p = 0.42). All available follow-up in the patients followed up to 24 months showed a separation between groups with 8.3% all cause death including cardiac death equivalents in the treatment group versus 13.2% in the control group (p = 0.94), corresponding to a 37% relative risk reduction for Tier 1 events for the treated patients compared to control patients on guideline directed medical therapy (GDMT).
   
   
2. For the second-tier, non-fatal major adverse cardiac events (MACCE), excluding those deemed procedure-related occurring within the first seven days and defined as heart failure hospitalization, stroke and myocardial infarction, 16.7% of treatment group had MACCE compared to 15.8% of the control group (p=0.82). All available follow-up data for patients followed up to 24 months showed a separation between groups, with 16.7% MACCE rate in the treatment group versus 23.6% in the control group (p=.76). This corresponds to an 18% relative risk reduction for MACCE over GDMT.