Pfizer announced topline data for the Phase 3 SPIRE-AI (AutoInjector) trial in which bococizumab, administered as a prefilled pen, met its co-primary endpoints. Those endpoint were defined as a percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks vs. placebo, and proportion of patients successfully operating the prefilled pen, defined as the percent of patients whose attempts to operate the pen met protocol-defined success.
The SPIRE-AI study was a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter, clinical trial (N=299) in patients with hyperlipidemia or mixed dyslipidemia receiving statins and whose LDL-C ≥70mg/dL that evaluated the efficacy, safety, tolerability, and subcutaneous administration of bococizumab 75mg and 150mg.
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Bococizumab is an investigational proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor being studied for its potential to lower LDL-C and improve cardiovascular outcomes in a broad range of high-risk primary and high-risk secondary prevention patients. It exerts its effects by blocking the PCSK9 protein, which interferes with LDL-C clearance.
The SPIRE-AI trial is the second completed study of 6 planned Phase 3 SPIRE lipid-lowering studies.
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