Amgen Presents Analysis Showing AMG 145 Significantly Reduced LDL Cholesterol

(RTTNews) - Amgen Inc. (AMGN) announced treatment with AMG 145 resulted in significant reductions in low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, of up to 59 percent in an efficacy analysis of pooled data from four 12-week Phase 2 studies evaluating AMG 145 in patient populations with high cholesterol.

AMG 145 is an investigational human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.

The company presented the data at the ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam.

Elevated LDL-C is recognized as a major risk factor for cardiovascular or CV disease. Despite the availability of various treatments to lower LDL-C, it is estimated that in two-thirds of treated, high-risk patients, LDL-C is not well-controlled.

The company said that results from the efficacy analysis showed mean reductions in LDL-C from baseline to week 12, as measured by preparative ultracentrifugation, ranged from 40 to 59 percent across AMG 145 doses in comparison to 0.1 to 0.5 percent for placebo (p=0.001). AMG 145 treatment was also associated with improvements in other lipid parameters, including high-density lipoprotein cholesterol or HDL-C, triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1, within each targeted dose frequency of AMG 145.

In the safety analysis, adverse events or AEs were observed more frequently with AMG 145 than placebo (57 percent vs. 49 percent) with the most frequent AEs being nasopharyngitis (8.3 percent vs. 7.5 percent) and upper respiratory tract infection (4.1 percent vs. 3.3 percent). Serious AEs were 2.0 percent with AMG 145 and 1.2 percent with placebo. The rates of injection-site reactions were similar between patients treated with AMG 145 and those treated with placebo (4.1 percent vs. 3.3 percent) while muscle-related AEs and anti-drug binding antibodies were 6.0 percent vs. 3.9 percent and 0.1 percent vs. 0.3 percent, respectively.