AMG 145: Phase Ib data

A double-blind, dose-escalation Phase Ib trial in 51 patients with high cholesterol who were receiving stable doses of statins showed that subcutaneous AMG 145 given every 2 weeks reduced mean LDL-C by up to 75% vs. placebo at week 6 in patients on low to moderate doses of statins and by up to 63% vs. placebo at week 6 in patients receiving high doses of statins (p<0.001 for both). Additionally, subcutaneous AMG 145 given every 4 weeks in patients on low to moderate doses of statins reduced mean LDL-C by up to 66% vs. placebo at week 8. AMG 145 also reduced mean levels of apolipoprotein B (APOB) by up to 54% vs. placebo (p<0.001). AMG 145 was well tolerated with no deaths or serious adverse events reported and no neutralizing antibodies to AMG 145 detected. Adverse events were similar between treatment groups and included nasopharyngitis, injection site hematoma and viral upper respiratory tract infection. The trial enrolled patients with an LDL-C of 70-200 mg/dL who were on stable daily <40 mg rosuvastatin, <80 mg atorvastatin or 20-80 mg simvastatin for >=1 month. Data were presented at the American College of Cardiology meeting in Chicago. Data from Phase II trials of AMG 145 are expected this year. ...