An injection of a human antibody reduced by 60% concentration of bad cholesterol
A monthly injection of an experimental agent manufactured by U.S. biotech Amgen reduced by 60% concentration of cholesterol in patients already treated with statins, according to a preliminary clinical study – Phase 1.
The trial was conducted on 61 patients who received AMG 145 injection every four weeks at a time receiving concentrated doses of statins, a anticholesterol which includes the drug Lipitor.
In patients who received such injections every two weeks, in combination with low or moderate doses of statins, lower bad cholesterol – low-density lipoprotein / low density lipoprotein (LDL) – was 75% after six weeks.
AMG 145 is a human antibody that neutralizes a protein called PCSK9 that reduces the liver’s ability to eliminate the bad cholesterol from blood.
Although statins are effective, many patients fail to achieve a satisfactory decrease their levels of LDL, while other patients can not tolerate this drug.
“Based on these results, Amgen initiated a Phase 2 clinical trial that will allow a wider understanding of the benefits and risks of PCSK9 protein neutralize to a wider variety of patients whose cholesterol levels can be controlled with existing therapies”, ie by using statins, the doctor Sean Harper said in a statement , who led the study and director of development at Amgen company.
“We expect the first results of this trial in the second half of this year,” said Sean Harper.
Amgen competes with the company Regeneron Pharmaceuticals, to develop and market launch an agent to block the action of PCSK9 protein.
Competitor experimental agent of the company Regeneron called REGN 727, was also successfully tested on patients with high LDL levels receiving statin therapy.
In some preliminary studies both competitors agents reduced LDL by 75% without significant side effects.