Phase III RN 316 (bococizumab) trials SPIRE-HR and SPIRE-FH meet endpoints for dyslipidaemia- Pfizer

Pfizer Inc. announced two additional Phase III RN 316 (bococizumab) trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint, demonstrating 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.

SPIRE-HR and SPIRE-FH are the third and fourth of six SPIRE lipid-lowering Phase III studies to complete and show positive results. The two remaining SPIRE lipid-lowering studies are anticipated to complete later in 2016. Both SPIRE-HR and SPIRE-FH continued for 52 weeks to assess 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. Bococizumab was generally safe and well tolerated in both trials.

Overall, the proportion of patients experiencing adverse events was similar among treatment groups, with one exception of a higher incidence of injection site reactions seen for patients on bococizumab compared to those on placebo in both trials. The majority of reported injection site reactions were mild. Complete study results from the SPIRE-HR and SPIRE-FH trials will be presented at a future scientific forum and will be part of the potential future regulatory filing for bococizumab.