SPIRE-HR and SPIRE-FH trials of bococizumab meet primary endpoints

Two Phase III trials of Pfizer’s bococizumab, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint.

The trials 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.

Pfizer says the 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.

A growing body of scientific evidence supports bococizumab

Commenting on the results, James M. Rusnak, MD, PhD, Chief Development Officer, Cardiovascular & Metabolic Disease, Pfizer Global Product Development, said: “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. 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 programme 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.”

Bococizumab is a PCSK9i being studied for its potential to lower LDL-C and improve cardiovascular outcomes in a broad range of high-risk primary and secondary prevention patients. It works by blocking the function of the PCSK9 protein, which interferes with the clearance of LDL-C, a leading known risk factor for heart disease. The investigational compound and has not received regulatory approval in any country.