Biocardia takes a pause for thought

Shares in Biocardia closed down 45% yesterday after an independent data-monitoring board concluded that the phase 3 trial of its autologous CardiAMP stem cell therapy for heart failure was unlikely to succeed. The company has suspended enrolment in the trial – this was proceeding slowly anyway, the board noted – to analyse one-year follow-up outcomes for both treated patients and those who had not yet received the cells. The review was based on data for 132 procedures involving 111 patients, both treated and untreated. Biocardia will continue to treat those patients already recruited, and said there appeared to be no treatment-emergent safety issues. The study might be able to restart without compromise after this one-year data analysis is completed, the group said, with an unchanged endpoint of survival, major adverse cardiac and cerebrovascular events and six-minute walk distance at 12 months. The company did not say whether this halt has implications for the other programme testing the CardiAMP cells, in chronic myocardial ischaemia. If it does, the company might end up reliant on its next most advanced projects, allogenic therapies for ischaemic heart failure and acute respiratory distress caused by Covid ongoing. Both are in phase 2.