The portion of Amgen’s Phase 3 trial of evolocumab that evaluated patients with high cholesterol who cannot tolerate statins has met goals related to the reduction of “bad” cholesterol, the company announced Jan. 23.
The Thousand Oaks-based biotechnology giant said benchmarks were met related to the percent reduction from baseline in low-density lipoprotein cholesterol, or LDL-C, at week 12, and the mean percent reductions from baseline in LDL-C at weeks 10 and 12.
Evolocumab is a human monoclonal antibody that inhibits a specific protein that reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood.
“We are pleased to continue to see promising results from the Phase 3 studies in our comprehensive development program for evolocumab,” said Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement. He added that the results “suggest that evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins.”
The Phase 3 program includes 13 trials, with a combined planned enrollment of more than 28,000 patients. This trial evaluated safety, tolerability and efficacy of evolocumab in 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins due to muscle-related side effects.
More than 71 million American adults have high LDL-C, a major risk factor for heart disease, according to the Centers for Disease Control and Prevention. While statins are effective, it is estimated that 5 percent to 15 percent of patients cannot tolerate statins, primarily due to muscle-related side effects.