Praluent meets Ph III goals in LDL apheresis therapy patients

US biotech for Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN) today released positive results from the Phase III ODYSSEY ESCAPE trial evaluating Praluent (alirocumab) injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy.

The trial met its primary endpoint, demonstrating that patients who added Praluent to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75%, compared to placebo (p less than 0.0001). 63% of patients treated with Praluent no longer required apheresis, compared to zero percent of placebo patients.

"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," said Bill Sasiela, vice president, program direction, at Regeneron.