PCSK9 Inhibitor Shows Promise in Phase 3 Trial


Experimental drug bococizumab could fill the unmet needs of patients at risk for cardiovascular disease.

Pfizer recently announced positive topline results from the second phase 3 trial for the investigational lipid lowering drug bococizumab.

Bococizumab is a proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9) inhibitor administered by a pre-filled pen.

The phase 3 SPIRE-AI (Auto Injector) study was a double-blind, placebo-controlled, randomized, parallel-group, multicenter clinical trial that lasted 12 weeks. It is the second of the 6 SPIRE phase 3 lipid-lowering studies to be completed.

Researchers enrolled 299 patients with hyperlipidemia or mixed dyslipidemia who were receiving statin therapy and had low-density lipoprotein cholesterol (LDL-C) of ≥70 mg/dL.

The study tested the safety, efficacy, tolerability, and subcutaneous administration of 150-mg and 75-mg of bococizumab with a pre-filled pen.

The co-primary endpoints were the percent change from baseline in LDL-C reduction at week 12 compared with placebo and the delivery system success rate, which was the percent of patients who successfully operated the pre-filled pen.

The drug was generally safe and well tolerated in the trial, and the overall amount of participants who experienced treatment-related adverse events were similar among the groups. However, this particular trial was not designed to distinguish safety event differences among the treatment groups.

“We are encouraged by this second positive result from our ongoing SPIRE clinical trial program evaluating bococizumab,” said researcher James M. Rusnak, MD, PhD. “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 3 program, including the 2 outcomes studies.”

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