Positive Topline Results from Phase 3 Study with auto-injector PCSK9 inhibitor


News - Apr. 12, 2016

The Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab met its co-primary endpoints: percent change from baseline in LDL-C reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen.

The Phase 3 SPIRE-AI study – a 12-week, double-blind, placebo-controlled, randomised, 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.

SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events) is an extensive research program to study bococizumab, an 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’s outcomes program for bococizumab is the only PCSK9i research program explicitly assessing cardiovascular outcomes in high-risk patients with an LDL-C ≥100mg/dL, despite the use of highly effective statins.

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.
 Press release Pfizer April 1, 2016

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