Pfizer Inc. announced that the Phase 3 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 3 lipid-lowering studies, and we expect it will be part of the potential regulatory filing for bococizumab.
“We are encouraged by this second positive result from our ongoing SPIRE clinical trial program evaluating bococizumab,” said James M. Rusnak, MD, PhD, Therapeutic Area Clinical Head for Cardiovascular and Metabolism. “We believe the SPIRE program and bococizumab have the potential to play an important role in understanding and helping to address the unmet needs of patients at high risk for cardiovascular disease. We continue to maintain focus on delivering our Phase 3 program, including the two outcomes studies.”
The Phase 3 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.
Filed Under: Drug Discovery