Pfizer’s cholesterol-lowering bococizumab shows promise in Phase III trials
pharmafile | April 1, 2016 | News story | Research and Development, Sales and Marketing | Pfizer, bococizumab, lipid, phase 3, phase III, spire, spire-ai
Pfizer (NYSE: PFE) has announced positive top line results from the SPIRE-AI Phase III clinical trial evaluating bococizumab. This protein interferes with the removal of low-density lipoproteins, the levels of which are a major risk factor for cardiovascular disease.
Bococizumab met its primary endpoint of percentage change from baseline in low-density lipoprotein cholesterol reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen.
This latest trial is the second of six SPIRE Phase III lipid-lowering studies, and Pfizer expect these positive results to be part of the potential regulatory filing for bococizumab. This 12-week, double blind, multicentre clinical trial involved 299 patients with hyperlipidemia or mixed dyslipidemia receiving statin therapy and assessed the efficacy, safety, tolerability and subcutaneous administration of bococizumab with a pre-filled pen.
James M. Rusnak, therapeutic area clinical head for cardiovascular and metabolism, comments: “We are encouraged by this second positive result from our ongoing SPIRE clinical trial program evaluating bococizumab. We believe the SPIRE program and bococizumab have the potential to play an important role in understanding and helping to address the unmet needs of patients at high risk for cardiovascular disease. We continue to maintain focus on delivering our Phase III program, including the two outcomes studies.”
Sean Murray
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