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Amgen Pooled Analysis Shows AMG 145 Significantly Reduced LDL Cholesterol

Amgen (NASDAQ: AMGN) today 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. Amgen 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 (CV) disease.1,2 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.3,4

"Millions of people around the world are unable to control their LDL cholesterol with currently available treatment options," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The data that we have accumulated in our Phase 2 clinical program is evidence that AMG 145 has the potential to help patients reach their cholesterol goals. We are conducting a large and comprehensive Phase 3 clinical program evaluating AMG 145 in multiple patient populations and utilizing two dosing schedules, with the hopes of advancing care and improving the lives of patients with uncontrolled high LDL cholesterol."

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 (HDL-C), triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1, within each targeted dose frequency of AMG 145.

In the safety analysis, adverse events (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.

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