LOS ANGELES: An experimental Pfizer Inc cholesterol drug showed promise in a small midstage trial, putting the world's largest drugmaker in the race to develop a medicine from a promising new class, albeit behind similar programs by Regeneron Pharmaceuticals Inc and Amgen Inc.
The drug, RN316, which Pfizer acquired with its purchase of Rinat Neuroscience, is a PCSK9 inhibitor, a class of biotech medicines that has generated great excitement in the industry.
The drugs work by blocking a protein that slows removal of bad LDL cholesterol from the blood and are considered potentially the most important advance in the field since widely used statin drugs, such as Pfizer's Lipitor.
In a 12-week trial of about 130 patients already on high doses of cholesterol-lowering statins, Pfizer's PCSK9 drug cut LDL cholesterol by a further 56 percent at the highest dose of 6 milligrams/kilogram of weight. The 3 mg/kg dose lowered LDL levels by 46 percent on top of statins, according to data unveiled on Monday.
Barry Gumbiner, executive director of clinical research for Pfizer's PCSK9 program, said the results were somewhat misleading because any patient whose LDL level fell below 25 had doses withheld as a precaution, skewing the overall results.
After four weeks, patients on the highest dose had LDL reductions of up to 80 percent before some had doses withheld, Pfizer explained. The data was presented at the American Heart Association scientific meeting in Los Angeles. PCSK9 drugs are intended for use by the millions of people who either cannot tolerate statins or cannot get their LDL levels down to target goals with statins and other drugs, including patients with a genetic condition that makes them predisposed to extreme, dangerously high cholesterol.
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