Mixed results for Celyad CHART-1 Phase III trial evaluating C-Cure cell therapy

Belgian biotech firm Celyad (Euronext Brussels: CYAD) today announced mixed headline results for CHART-1, its European Phase III clinical trial for its lead cardiovascular disease product candidate, C-Cure cell therapy, with the news sending the firm’s share plummeting 41.5% to 23.20 euros by close of trading.

Across the complete trial population, a positive trend was clearly identifiable. However, a statistically-significant difference between treatment and control (sham procedure), the primary endpoint, was not reached.

For patients representing 60% of the overall study population and categorized by their End Diastolic Volume (EDV) at inclusion, significance was met for the primary endpoint (p = 0.015). Most importantly, in this subgroup, a strong trend or a statistical significant positive difference was seen in all individual elements of the composite primary endpoint (Mortality, Worsening Heart Failure Events, Quality of Life, 6 minutes Walking Test, End Systolic Volume and Ejection Fraction). The study procedure was well tolerated with no safety concerns.