Sanofi & Regeneron’s Praluent cholesterol treatment smashes Phase III target
pharmafile | August 30, 2016 | News story | Manufacturing and Production, Research and Development | Regeneron, Sanofi, apheresis, cholesterol, phase III
Sanofi and Regeneron have announced that their Praluent injection generated positive Phase III results investigating patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
The trial, named ODYSSEY ESCAPE, demonstrated that adding Praluent to existing therapy reduced LDL cholesterol by approximately 50% from baseline (compared to 2% increase for placebo) and significantly reduced the need for apheresis treatment by 75% compared to placebo.
Apheresis is an invasive, time-consuming and expensive procedure where bad (LDL) cholesterol is removed from the blood, and is usually reserved for high-risk patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy. Treatment may cost up to $100,000, and there are only around 60 apheresis centres in the US.
Despite being treated with apheresis and entering the trial with very high LDL cholesterol levels, 63% of patients treated with Praluent no longer required apheresis therapy after six weeks. At this same time point, the average LDL cholesterol level among the Praluent-treated group was 2.3 mmol/L (90 mg/dL), compared to 4.8 mmol/L (185 mg/dL) in the placebo group. 93% of patients experienced at least a 50% reduction in apheresis procedures.
“Findings from ODYSSEY ESCAPE suggest a role for Praluent in the overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to reduce the need for burdensome apheresis treatments,” commented Patrick M Moriarty, director of the Department of Internal Medicine at the Atherosclerosis and Lipoprotein Apheresis Center, University of Kansas Medical Center. “This is a significant development in the continued investigation of this drug in HeFH patients, because it is the first clinical trial to demonstrate that Praluent reduced the frequency of apheresis therapy.”
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol levels in the blood. The drug also claims to be the only PCSK9 inhibitor available in two dosages with two levels of efficacy (75 mg and 150 mg), allowing physicians to select the dose based on a patient’s LDL cholesterol lowering needs.
Matt Fellows
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