(HoFH), according to a from the company developing the drug.
LDL cholesterol levels were 255 mg/dL on average for patients at the outset of the trial despite treatment with other lipid-lowering therapies; however, combining this drug with lipid-lowering therapies including maximally-tolerated statins, PCSK9 inhibitors, and LDL apheresis, reduced LDL cholesterol by an average of 49% by week 24 relative to treatment with lipid-lowering therapies alone (P less than .0001). Furthermore, 47% of patients taking evinacumab achieved LDL cholesterol levels under 100 mg/dL by that time point versus 23% of those taking lipid-lowering therapies only.
Treatment with evinacumab showed lowering effects as early as the first assessment at 2 weeks, and these effects were maintained.
HoFH is an inherited, rare, but serious condition estimated to affect 1,300 people in the United States; it can lead to early atherosclerotic disease, and even teenagers with this genetic disorder can suffer cardiac events. Further details and data from the trial, called ELIPSE HoFH, will be reported at a future medical meeting, and will be submitted to the Food and Drug Administration for consideration.
Evinacumab is an investigational, fully-human, monoclonal antibody that specifically binds to angiopoietin-like protein 3 (ANGPTL3), which acts as an inhibitor of lipoprotein lipase and endothelial lipase, and appears to play a central role in lipoprotein metabolism.
Evinacumab was granted breakthrough therapy designation for treatment of HoFH by the FDA in 2017, whichan expedited review and development process for this drug because preliminary results have suggested it could have a substantial effect on a life-threatening or serious condition.
The company’scan be read on its website.