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Pfizer's PCSK9 Inhibitor Tops Two Additional Phase III Studies

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Pfizer Inc. (PFE - Free Report) announced that two additional phase III studies (SPIRE-HR and SPIRE-FH) on its PCSK9 inhibitor, bococizumab, have met the primary endpoint in patients at high and very high risk of cardiovascular events.

The SPIRE-HR study was conducted on adults with primary hyperlipidemia or mixed dyslipidemia at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin therapy whose LDL-C ≥70 mg/dL. On the other hand, the SPIRE-FH study involved adults with heterozygous familial hypercholesterolemia (HeFH) who were at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin.

Data from the studies demonstrated a significant reduction in the percent change from baseline in LDL-C at 12 weeks compared to placebo. In both the studies, bococizumab was found to be generally safe and well tolerated.

SPIRE-HR and SPIRE-FH are the third and fourth successful studies in Pfizer’s phase III program (SPIRE - Studies of PCSK9 Inhibition and the Reduction of vascular Events) on bococizumab. The SPIRE program consists of six lipid-lowering studies – SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL – and two cardiovascular outcomes studies – SPIRE-1 and SPIRE-2.

Two of the remaining SPIRE lipid-lowering studies are expected to be completed later this year. Meanwhile, full results from SPIRE-HR and SPIRE-FH studies will be presented at an upcoming scientific meeting and will be used for regulatory filing for bococizumab.

We note that PCSK9 is a protein that lowers the liver's ability to remove ‘bad’ cholesterol (LDL-C) from the blood. Although the market represents huge commercial potential, Pfizer will be a late entrant in the market given the presence of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) /Sanofi’s (SNY - Free Report) Praluent and Amgen Inc.’s (AMGN - Free Report) Repatha.

Currently, Pfizer carries a Zacks Rank #1 (Strong Buy) while Amgen is a Zacks Rank #2 (Buy) stock in the health care sector.

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