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.
The 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 greater than or equal to 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.
Bococizumab is an investigational PCSK9i 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 works by blocking the function of the PCSK9 protein, which interferes with the clearance of LDL-C, a leading known risk factor for heart disease.
Pfizer has created SPIRE ( Studies of PCSK9 Inhibition and the Reduction of vascular Events ), an extensive research program to study Bococizumab, its investigational PCSK9i.
The SPIRE Phase 3 global clinical development program involves approximately 32,000 patients and consists of six lipid-lowering studies ( SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL ) as well as two cardiovascular outcomes studies ( SPIRE-1 and SPIRE-2 ).
The lipid-lowering studies are evaluating LDL-C lowering efficacy, safety, and tolerability of Bococizumab in adult patients at risk of cardiovascular events, while the two cardiovascular outcomes studies are investigating the ability of Bococizumab to reduce cardiovascular disease in a broad range of high-risk primary and secondary prevention patients.
SPIRE-SI ( Statin Intolerance ), the first of the six SPIRE phase 3 lipid-lowering studies to be completed met its primary endpoint of lowering LDL-C in adult patients with hyperlipidemia who are intolerant to statins.
No new or unexpected safety findings for bococizumab were observed in the study. ( Xagena )
Source: Pfizer, 2016