US drug maker Pfizer has reported positive results from two Phase III trials, studies of PCSK9 inhibition and the reduction of vascular events (SPIRE) HR (high risk) and SPIRE-FH (familial hypercholesterolemia) of bococizumab at high and very high risk for cardiovascular events.
Bococizumab is an investigational proprotein convertase subtilisin kexin type 9 and acts as a PCSK9 protein inhibitor.
SPIRE-HR and SPIRE-FH are the third and fourth of six SPIRE lipid-lowering Phase III trials, which intend to lower the lipid profile of the patients.
The SPIRE-HR is a double-blind, randomised, placebo-controlled, parallel-group, multicentre trial conducted over a period of 52 weeks and was designed to determine the efficacy, safety and tolerability of bococizumab to minimise lipoprotein cholesterol (LDL-C) compared to placebo.
The trial involved 711 adults with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for cardiovascular events and was administered with a maximally tolerated dose of statin therapy.
The double blind, randomised, placebo controlled, parallel group, multicentre SPIRE-FH study was conducted over a period of 52 weeks to determine the efficacy, safety and tolerability of bococizumab.
It included 370 adults with heterozygous familial hypercholesterolemia (HeFH) and at high and very high risk of cardiovascular events and was administered with a maximally tolerated dose of statin.
Results of both the studies have showed a reduction in the lipid profile after 12 weeks compared to placebo while being tolerable and safe.
Pfizer global product development cardiovascular and metabolic disease chief development officer James Rusnak said: "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 inhibits the function of the PCSK9 protein that blocks the LDL-C from being cleared, which is known to be a leading cause of heart disease.
Image: Illustration of lipoprotein structure. Photo: courtesy of Xvazquez via Wikipedia.