Amgen, Regeneron PCSK9s look similar so far, but more data in LDL due this year
The early Phase III data appear similar for competing anti-PCSK9 mAbs from Amgen Inc. on one end and partners Regeneron Pharmaceuticals Inc. and Sanofi on the other. But starting mid-year, additional data in the populations where PCSK9 inhibitors are most likely to be used - familial hypercholesterolemia or statin intolerance - should begin to provide a better view on how the mAbs will compete.
Inhibiting proprotein convertase subtilisin/kexin 9 reduces LDL-C by preventing the protein from enhancing the degradation of LDL receptors that clear LDL from the circulation.
When PCSK9 was discovered to play a role in the same pathway as statins, the hypothesis was that blocking the target could enhance their cholesterol-lowering effects. Statins inhibit HMG-CoA reductase, which leads to increased expression of LDL receptors.
Amgen's evolocumab and alirocumab from Regeneron and Sanofi are the most advanced PCSK9 inhibitors.
The American College of Cardiology (ACC) meeting in late March saw a plethora of data for both programs. All the trials had LDL reductions as the primary endpoint.
Amgen's presentations included results from five Phase III trials. These included monotherapy studies in hypercholesterolemia patients not receiving lipid-lowering therapy; heterozygous familial hypercholesterolemia (heFH) patients; and statin-intolerant patients.
The molecule also was tested in combination with optimized statin therapy vs. statin therapy alone in hypercholesterolemia patients with varying degrees of CV risk factors.