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New phase 3 studies of bococizumab show promise

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The SPIRE-HR and SPIRE-FH phase 3 studies of the PCSK9 inhibitor bococizumab have met their primary endpoints of significant reduction in percent change in LDL from baseline to 12 weeks in patients with familial hypercholesterolemia and primary hyperlipidemia or mixed dyslipidemia at high and very high risk for CVD, according to a press release issued by Pfizer.

“These positive results add the growing body of scientific evidence in support of bococizumab for lowering LDL cholesterol in patients at high risk for cardiovascular events,” James M. Rusnak, MD, PhD, chief development officer of Cardiovascular and Metabolic Disease at Pfizer, said in a press release.

The SPIRE-HR double blind, randomized, placebo-controlled, multicenter study included 711 patients with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for CV events who were receiving the highest tolerated dose of statin therapy with LDL levels 70 mg/dL. Patients in SPIRE-HR were considered at high and very high risk if they had a history of CVD.

The SPIRE-FH study included 370 patients with heterozygous familial hypercholesterolemia at high and very high risk of CV events who were receiving maximum tolerated doses of statin therapy. Patients with HeFH were considered to be at high risk for CV events if they had a history of CVD, diabetes or chronic kidney disease and LDL 70 mg/dL or without a history of CVD, chronic kidney disease and an LDL 100 mg/dL or diabetes.

According to the topline results, in both trials, bococizumab was safe and tolerated. The number of patients in both groups who experienced adverse events was similar, with the exception of a higher incidence of injection-site reactions among patients assigned bococizumab compared with placebo in both trials, according to the release.

Both SPIRE-HR and SPIRE-FH continued for 52 weeks to assess the longer-term efficacy of bococizumab in these patient populations, according to the release.

Complete study results from the SPIRE-HR and SPIRE-FH trials will be presented at a future scientific meeting and will be part of the potential future regulatory filing for bococizumab, according to the release. – by Dave Quaile

Disclosure: Rusnak is an employee of Pfizer Global Development.