Pfizer 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.
“These positive results add to the growing body of scientific evidence in support of bococizumab for lowering LDL-cholesterol in patients at high risk for cardiovascular events,” said James M. Rusnak, MD, PhD, Chief Development Officer, Cardiovascular & Metabolic Disease, Pfizer Global Product Development. “The high burden of cardiovascular disease suggests that more treatment options are needed to help lower cholesterol and reduce cardiovascular risk in these patients. 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.”
About SPIRE-HR study
The double-blind, randomized, placebo-controlled, parallel-group, multicenter, 52-week study evaluated the efficacy, safety and tolerability of bococizumab to lower LDL-C compared to placebo. The 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.
Patients in the SPIRE-HR study were considered at high and very high risk for a future cardiovascular event if they had a known history of cardiovascular disease, including coronary heart disease or atherosclerotic diseases, diabetes or chronic kidney disease.
About SPIRE-FH study
The SPIRE-FH double-blind, randomized, placebo-controlled, parallel-group, multicenter, 52-week study evaluated the efficacy, safety and tolerability of bococizumab to lower LDL-C compared to placebo. The 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.
HeFH is a difficult-to-treat genetic condition that causes high LDL-C at birth putting patients at high risk for cardiovascular events at an early age.1,2
Patients with HeFH in the SPIRE-FH study were considered at high and very high risk for a future cardiovascular event if they had a known history of cardiovascular disease, diabetes or chronic kidney disease and an LDL-C ≥ 70 mg/dL or without a known history of cardiovascular disease, diabetes or chronic kidney disease with an LDL-C ≥100 mg/dL; patients were required to be on the highest locally approved dose of an eligible statin or on the maximally tolerated dose.
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.
Filed Under: Drug Discovery