Phase III trial of Praluent (alirocumab) meets endpoint for dyslipidaemia in ODYSSEY JAPAN trial - Regeneron/Sanofi

Regeneron Pharmaceuticals and Sanofi have announced that the Phase III ODYSSEY JAPAN trial of Praluent (alirocumab) Injection, for dyslipidaemia met its primary endpoint. At week 24, patients in the Praluent group experienced an average 64 percent greater reduction from baseline in their bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C), when added to current standard of care including statins, compared to standard of care alone (p less than 0.0001). Patients were started on the lower dose of 75 mg, with the option to adjust their dose to 150 mg if they had not achieved their LDL-C goal (as defined by the Japan Atherosclerosis Society guidelines) at week 8.

At week 24, 97% of patients in the Praluent group reached their LDL-C treatment goal, compared to 10% for placebo (p <0.0001). 99% of patients treated with Praluent remained on the lower dose; two patients required adjustment to the higher dose. The trial involved 216 Japanese patients with hypercholesterolemia at high cardiovascular (CV) risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH). Results were presented today for the first time at the Annual Scientific Meeting of the Japan Atherosclerosis Society.

Comment: The drug is currently filed in both the EU and US. Competitors include: Repatha (evolocumab) from Amgen and ALN PCS from The Medicines Company and Alnylam. In addition, there is RN 316 (bococizumab) from Pfizer which is in Phase III trials.