Sanofi and Regeneron have announced positive topline results from their Phase 3 Praluent® (alirocumab) study.
The positive results came from the Phase 3 ODYSSEY ESCAPE trial evaluating Praluent injection in patients with an inherited form of high cholesterol (heterozygous familial hypercholesterolemia (HeFH)), whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy.
Apheresis is an invasive and lengthy procedure similar to kidney dialysis, where LDL (bad) cholesterol is removed from the blood. It is known to be hard to access for many patients.
The trial met its primary endpoint, demonstrating that adding Praluent to these patients’ current treatment regimes significantly reduced the frequency of their apheresis therapy by 75%, compared to placebo.
63% of patients treated with Praluent no longer required apheresis. This compared to 0% of placebo patients.
Bill Sasiela, Regeneron’s VP, Program Direction, said: “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.”
Dr Jay Edelberg, Sanofi’s Head of Cardiovascular Development, said: “The results demonstrate that treatment with Praluent may help these patients decrease the frequency or even eliminate the need for apheresis.”
The most common adverse events in the trial included fatigue, nasopharyngitis, diarrhoea, headache, and back pain.