Inclacumab: Phase II data

The double-blind, international Phase II SELECT-ACS trial in 322 evaluable patients with NSTEMI who underwent PCI showed that a single IV infusion of 20 mg/kg inclacumab missed the co-primary endpoints of reducing cardiac troponin I levels from baseline to 16 and 24 hours post-PCI vs. placebo. Specifically, inclacumab led to a non-significant 22.4% placebo-adjusted geometric mean reduction from baseline in cardiac troponin I levels at 16 hours post-PCI (p=0.066) and a non-significant 24.4% placebo-adjusted geometric mean reduction on the endpoint at 24 hours post-PCI (p=0.053). On secondary endpoints, inclacumab led to a placebo-adjusted geometric mean reduction from baseline in peak troponin I levels of 23.8% (p=0.05) and in AUC troponin I levels over 24 hours of 33.9% (p=0.08). Additionally, inclacumab led to placebo-adjusted geometric mean reductions from baseline in creatine kinase MB of 16.3% at 16 hours post-PCI (p=0.09) and of 17.4% at 24 hours post-PCI (p=0.06). Furthermore, a significantly smaller proportion of patients receiving inclacumab had an increase in creatine kinase MB of >3 times the upper limit of normal within 24 hours of PCI (8.9% vs. 18.3%, p=0.05).

A single IV infusion of 5 mg/kg inclacumab also missed both co-primary endpoints. Specifically, low-dose inclacumab led to a 3.4% placebo-adjusted geometric mean reduction from baseline in cardiac troponin I levels at 16 hours post-PCI (p=0.81) and a 1.4% placebo-adjusted geometric mean reduction at 24 hours post-PCI (p=0.93). There were no significant differences in adverse events between treatment groups. There were 4 deaths in the low-dose inclacumab arm, 2 deaths in the high-dose inclacumab arm and 0 deaths in the placebo arm. Data were published in the Journal of the American College of Cardiology and presented at the American College of Cardiology meeting in San Francisco. ...