Pfizer's PCSK9 meets Phase-II primary endpoint
Pfizer has issued the results of its Phase-II trial for PCSK9 cholesterol lowering treatment bococizumab (RN316). The drugmaker said the study met its primary endpoint across all doses, “showing that bococizumab significantly reduced lipoprotein cholesterol (LDL-C) from baseline compared to placebo in adults with high cholesterol also taking statin therapy."
Patients were either dosed twice monthly, or once monthly. Both groups “were associated with significant placebo-adjusted reductions in LDL-C” by week 12 of therapy, the drugmaker stated.
Pfizer's global medicines development lead, Dr. Steven Romano, said “we are pleased with the outcome of this Phase 2b study and continue to maintain focus on developing our Phase-III program, which includes two CV outcome studies in populations at high risk from cardiovascular events. Recent guidelines emphasize the reduction of CV risk as the primary goal of lipid therapy" for those patients, he added. The drug's Phase-III trial began in October 2013.