Sanofi and Regeneron meet endpoint in Phase III Praluent study
pharmafile | March 23, 2016 | News story | Research and Development | Regeneron, Sanofi, endpoint, escape, hefh, odyssey, phase 3, phase III, positive, praulent, trial
Sanofi and Regeneron Pharmaceuticals have announced that their Phase III ODYSSEY ESCAPE clinical trial evaluating Praluent (alirocumab) met its primary endpoint.
Praluent is a proproetin convertase subtilisin/kexin type 9 (or PCSK9) inhibitor that is being evaluated as a treatment in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
With HeFH, cholesterol levels require chronic, weekly or bi-weekly apheresis therapy, which is a therapy where bad cholesterol is removed from the blood in a process similar to kidney dialysis.
In this Phase III clinical trial, injections of Praluent were added to existing treatment regimen and significantly reduced the frequency of patient’s apheresis therapy by 75%, compared to placebo. 63% of patients treated with Praluent no longer required apheresis, compared to zero percent of placebo patients.
Bill Sasiela, VP, Program Direction, Regeneron, says: “This is the first time a PCSK9 inhibitor has shown in a clinical study that it reduced the frequency of apheresis therapy, an invasive, difficult to access, time-consuming and expensive treatment for some of the most difficult-to-treat patients. The ODYSSEY clinical trial program was designed to understand the effect of Praluent on many different patient populations with a high degree of unmet need who required further reduction of their LDL cholesterol.”
Jay Edelberg, head of cardiovascular development at Sanofi, comments: “Despite statins, a subset of patients with HeFH are unable to sufficiently reduce their LDL cholesterol, and require regular apheresis treatment. The results demonstrate that treatment with Praluent may help these patients decrease the frequency or even eliminate the need for apheresis.”
Praluent was the subject of a recent court case which could see Sanofi and Regeneron’s sales of the drug limited in the US, after a ruling was made in favour of Amgen. You can read more about it here.
Sean Murray
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