Amgen Reports Positive Results From Phase 3 Evolucumab TESLA Trial

Amgen announced positive top-line results from the phase III TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial assessing evolocumab. The study achieved its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C).

The reduction in LDL-C was clinically meaningful and statistically significant. TESLA was a two-part Phase 2/3 trial assessing evolucumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder marked by highly elevated LDL-C at an early age. Phase III TESLA trial measured the safety, efficacy, and tolerability of evolocumab against placebo in 49 adult and adolescent patients age 12 to less than 18 years of age with HoFH who were receiving stable doses of statin and other lipid-lowering medication. Patients involved in the trial were randomized to take evolocumab 420 mg subcutaneous or placebo subcutaneously monthly.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said “We are encouraged by the data from another Phase 3 trial in our clinical development program showing that evolocumab reduces LDL cholesterol and in this case, in patients with a rare and serious genetic condition. These results add to the data from our five previously announced positive Phase 3 studies of evolocumab in other patient populations.”

Evolocumab is an experimental fully human monoclonal antibody designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), which decreases the liver’s ability to remove LDL-C from the blood. The safety profile of the drug was balanced in general across treatment groups.

Elevatd LDL-C is known to be a major risk factor for cardiovascular disease. HoFH is serious and reare inherited disease that can cause or lead to high levels of LD-C at an early age. The rare form of familial hypercholesterolemia occurs in around one in a million individuals, who possess altered copies of a cholesterol regulating gene that result in absent or defective LDL receptor function. The disease can cause up to four-fold increase in LDL-C levels.

The company said it will present details of the Phase III TESLA trial on an upcoming future medical conference and for subsequent publication.