BioCentury
ARTICLE | Clinical News

ALN-PCSsc: Phase I data

September 7, 2015 7:00 AM UTC

A single-blind, placebo-controlled, U.K. Phase I trial in 69 healthy subjects on or off statins with elevated baseline LDL-C levels of >100 mg/dL showed that single and multiple doses of subcutaneous ALN-PCSsc were generally well tolerated with no serious adverse events reported. Mean maximum percent PCSK9 knockdown relative to baseline for single doses of ALN-PCSsc was 54% at the 25 mg dose, 49% at the 100 mg dose, 78% at the 300 mg dose (p<0.001), 76% at the 500 mg dose (p<0.001) and 82% at the 800 mg dose (p<0.001) vs. 29% for placebo. Mean maximum percent reductions in LDL-C relative to baseline for single doses of ALN-PCSsc were 34% at the 25 mg dose, 43% at the 100 mg dose, 53% at the 300 mg dose, 55% at the 500 mg dose (p<0.05) and 58% at the 800 mg dose (p<0.01) vs. 19% for placebo. ...