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|Amgen Announces Positive Top-Line Results From Phase 3 TESLA Trial Of Evolocumab (AMG 145) In Patients With Homozygous Familial Hypercholesterolemia|
TESLA was a two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C at an early age.2 The Phase 3 TESLA trial evaluated the safety, tolerability and efficacy of evolocumab compared to placebo in 49 adult and adolescent (12 to less than 18 years of age) patients with HoFH who were on a stable dose of statin therapy and other lipid-lowering medication. Patients were randomized to evolocumab 420 mg subcutaneous monthly or placebo subcutaneous monthly.
Safety was generally balanced across treatment groups. The most common adverse events in the evolocumab group (more than one subject) were upper respiratory tract infection, influenza, gastroenteritis and nasopharyngitis.
"Homozygous familial hypercholesterolemia is a rare and devastating disease characterized by extremely high LDL-C levels that increase cardiovascular risk in these patients, many of whom are affected at an early age," said
Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.3 HoFH is a rare, serious inherited condition that can lead to/cause high levels of LDL-C at an early age.2 It is a rare form of familial hypercholesterolemia occurring in approximately one in a million individuals, who have two altered copies of a cholesterol regulating gene (one from each parent) that result in absent or defective LDL receptor function.2,4 HoFH can cause a four-fold increase in LDL-C levels (e.g., 400-1,000 mg/dL).2,5
"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," Harper added. "These results add to the data from our five previously announced positive Phase 3 studies of evolocumab in other patient populations."
Details of the Phase 3 TESLA trial will be submitted to a future medical conference and for publication.
TESLA Trial Design
The Phase 2 12-week, open-label, single-arm, multicenter part of the TESLA trial evaluated eight patients with HoFH who were on stable drug therapy for four weeks or more. Patients received evolocumab 420 mg subcutaneous once monthly for a minimum of 12 weeks, followed by every two weeks for another 12 weeks. The primary endpoint was the percent reduction from baseline in LDL-C at week 12. Positive results from the Phase 2 TESLA trial were presented at the 2013
The Phase 3 12-week, double-blind, randomized, placebo-controlled, multicenter part of the TESLA trial evaluated evolocumab in 49 patients with HoFH (LDL-C >130 mg/dL) who were on a stable dose of statin therapy and lipid-lowering medication. Patients were randomized to evolocumab 420 mg subcutaneous monthly or placebo subcutaneous monthly. The primary endpoint was the percent reduction from baseline in LDL-C at week 12. Secondary endpoints included mean percent change from baseline in LDL-C, apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)) at weeks 6 and 12, and percent change from baseline in ApoB and Lp(a) at week 12.
The Phase 3 program includes 14 trials to evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; as well as the administration of evolocumab (THOMAS-1 and THOMAS-2).
Five studies in the evolocumab Phase 3 program will provide long-term safety and efficacy data. These include FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease; DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) in patients with hyperlipidemia at risk for cardiovascular disease; OSLER-2 (Open Label Study of Long TERm Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound), which will determine the effect of evolocumab on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization; and TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects with Genetic LDL Disorders), which will assess the long-term safety and efficacy of evolocumab on LDL-C in patients with severe familial hypercholesterolemia.
No forward-looking statement can be guaranteed and actual results may differ materially from those
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