PCSK9 inhibitors against cholesterol problems perform well

Sanofi has reported Phase II data for a new drug candidate for lowering cholesterol levels in patients already taking statins. Over an 8-12 week period, the candidate reduced low density lipoprotein (LDL) cholesterol – so-called ‘bad’ cholesterol – by 40-72%, compared with 5% for placebo treatment. The 183 patients in the trial all had high levels of LDL cholesterol despite taking atorvastatin (the generic name for Pfizer’s Lipitor). The candidate (SAR236553/REGN727) is a monoclonal antibody, administered by injection, that targets the PCSK9 enzyme. If approved would be a first-in-class drug. It was created by US drugmaker Regeneron – which started working with Sanofi in this area in 2007, and in 2009 signed a $160 million (£100 million at current exchange rates) licensing deal.

Meanwhile, Amgen has reported Phase I data for its own monoclonal antibody PCSK9 inhibitor (AMG145), also aimed at lowering cholesterol levels in patients taking statins. In a 51 patient study, AMG145 reduced LDL cholesterol by up to 75% when taken every two weeks over a six week period by patients already taking ‘low to moderate’ doses of statins. The reductions in LDL cholesterol levels were lower for patients taking high doses of statins.