Pfizer reports Phase IIb data for PCSK9 inhibitor

Pfizer Inc. (NYSE:PFE) said subcutaneous bococizumab ( PF-4950615) met the primary endpoint of reducing LDL-C from baseline to week 12 vs. placebo in a Phase IIb trial to treat hypercholesterolemia in patients receiving a statin. Patients received subcutaneous bococizumab once monthly at 200 or 300 mg and twice monthly at 50, 100 or 150 mg. Pfizer said the greatest reductions in mean LDL-C were reported in the once-monthly 300 mg bococizumab and twice-monthly 150 mg bococizumab arms (placebo-adjusted reductions of 44.9 and 53.4 mg/dL, respectively). The double-blind, U.S. trial enrolled 354 patients with an LDL-C of 80 mg/dL or greater on background statin treatment. Data are slated to be presented on Sunday at the American College of Cardiology meeting.

The Phase III program of bococizumab consists of two cardiovascular outcome trials -- SPIRE-1 and SPIRE-2 -- and multiple lipid-lowering studies in more than 22,000 patients. The first Phase III trial is expected to complete in December 2015. Bococizumab is a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9). ...