BioCardia reports interim efficacy results in Phase 3 CardiAMP Cell Therapy

BioCardia 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 for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction, or 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. 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. For the first-tier, all cause death, including cardiac death equivalents, there were 5.6% of CardiAMP treatment patients versus 5.3% for the control group. 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 , corresponding to a 37% relative risk reduction for Tier 1 events for the treated patients compared to control patients on guideline directed medical therapy. For the second-tier, non-fatal major adverse cardiac events, 16.7% of treatment group had MACCE compared to 15.8% of the control group. Based on these measures at one year follow-up, the 250-patient randomized controlled study is unlikely to meet its primary three-tiered FS efficacy endpoint. This interim randomized study data does not include the study’s roll-in open label cohort of 10 patients treated who did well with 100% survival at two-year follow-up.