Bococizumab 'Meets' LDL-C End Point in SPIRE-AI, Pfizer Says

April 01, 2016

NEW YORK, NY — Pfizer says that a 12-week, phase 3 trial with 299 statin-treated patients with hyperlipidemia or mixed dyslipidemia, given either placebo or the company's investigational agent bococizumab, "met its co–primary end points," indicating a successful showing for the proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor[1].

Those end points consisted of 12-week percent change from baseline in LDL cholesterol and success at using the trial's hallmark prefilled injector pen, both at the 150-mg bococizumab dosage. In the trial, the autoinjector (AI) segment of its Studies of PCSK9 Inhibition and the Reduction of Vascular Events (SPIRE) series of trials (SPIRE-AI), the drug was given at 150-mg and 75-mg dosages, in both cases every 2 weeks for 10 weeks.

Bococizumab, like the already-approved alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen), is a monoclonal antibody that inhibits PCSK9, a protein that itself suppresses LDL-C clearance. None of the PCSK9 inhibitors have completed outcomes trials, but those are ongoing for all three agents.

Although the study was not powered for safety events, the company says, "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."

In the same statement, Pfizer reported that another in the same family of trials, the SPIRE-SI study, which randomized 184 patients with statin intolerance to bococizumab, atorvastatin, or placebo also met its primary end point (percentage change in LDL-C at week 12) without "new or unexpected safety findings."

SPIRE-SI and SPIRE-AI are the first of six SPIRE trials to be completed, according to Pfizer; two of the others ongoing are outcomes trials.

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