The US Food and Drug Administration has approved Tekmira Pharamceuticals' investigational new drug application for its siRNA-based hypercholesterolemia drug ApoB SNALP, the company said this week.
The drug targets apolipoprotein B, a protein involved in cholesterol metabolism. In the planned phase I study, escalating doses of ApoB SNALP will be examine for safety, tolerability, and pharmacokinetics in about 30 adults with elevated low-density lipoprotein cholesterol, according to the company.
The trial is also expected to yield some data on the drug's ability to lower serum LDL cholesterol levels, Tekmira added. Results from the study are expected in late 2009 or early 2010.