Pfizer Says SPIRE-HR And SPIRE-FH Trials Meet Primary Endpoints

(RTTNews) - Pfizer Inc. (PFE) announced two additional Phase 3 bococizumab trials, SPIRE-HR (High Risk) 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 3 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.