SPIRE-AI Phase III trial success for bococizumab pre- filled pen to treat dyslipidaemia,-Pfizer

Pfizer Inc. announced that the Phase III SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen.

The SPIRE-AI trial is the second study completed of the six SPIRE Phase III lipid-lowering studies. The Phase III SPIRE-AI study – a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter, clinical trial in 299 patients with hyperlipidemia or mixed dyslipidemia receiving statin therapy and whose LDL-C ≥70 mg/dL – assessed the efficacy, safety, tolerability and subcutaneous administration of bococizumab 150mg and 75mg with a pre-filled pen. Co-primary endpoints included the percent change from baseline in fasting LDL-C at week 12 and the delivery system success rate, defined as the percent of patients whose attempts to operate the pre-filled pen met protocol-defined success. Bococizumab was generally safe and well tolerated in this trial. Overall, the proportion of subjects experiencing treatment-related adverse events was similar among treatment groups. However, the trial was not designed to discern safety event differences among treatment groups. Complete study results of the SPIRE-AI trial will be presented at a future scientific forum.