Two additional phase 3 lipid-lowering trials of Bococizumab meet primary endpoints

The trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), demonstrated a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a maximally tolerated dose of a highly effective statin.

Both the trials continued for 52 weeks to evaluate the longer-term efficacy and safety of bococizumab, an investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i), in patients at high and very high risk for cardiovascular events.

The SPIRE-HR study included 711 adults with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for cardiovascular events receiving a maximally tolerated dose of statin therapy whose LDL-C =70 mg/dL.

The SPIRE-FH study included 370 adults with heterozygous familial hypercholesterolemia (HeFH) and at high and very high risk of cardiovascular events receiving a maximally tolerated dose of statin.

Bococizumab, which has not received regulatory approval in any country, was generally safe and well tolerated in both trials.

The trails are the third and fourth of six SPIRE lipid-lowering phase 3 studies to complete and demonstrate positive results.

Pfizer expects to complete the two remaining SPIRE lipid-lowering studies later this year.

Pfizer Global Product Development chief development officer, cardiovascular & metabolic disease James Rusnak said: "Our goal with the extensive SPIRE clinical program is to evaluate whether bococizumab not only reduces cholesterol, but also reduces the risk of cardiovascular events in a broad range of high-risk patients, including those without a history of heart disease."