A Dutch biotech has proved its resurrected Amgen drug is capable of significantly lowering “bad” cholesterol in a handful of mid-stage trials in recent years, and a new analysis suggests the therapy also lowers a key risk factor for heart disease.
NewAmsterdam Pharma said Tuesday that a 10 mg dose of obicetrapib on top of high-intensity statins reduced a form of cholesterol called lipoprotein (a), or Lp(a), by 57% in the Phase 2 ROSE1 trial. In a separate Phase 2 trial dubbed ROSE2, which was also detailed at the European Atherosclerosis Society’s annual meeting, obicetrapib lowered Lp(a) by 47%.
Lp(a) has been an elusive target in drug development. High Lp(a) levels are genetic and a risk factor for heart disease, heart attack and stroke. There are no drugs specifically approved to reduce Lp(a) levels, but several are in clinical development, including Amgen’s Phase 3 olpasiran and Novartis and Ionis’ Phase 3 pelacarsen.
Obicetrapib is a cholesteryl ester transfer protein (CETP) inhibitor. It previously showed statistically significant reductions in LDL-C, also known as “bad” cholesterol, alone and in combination with ezetimibe, in Phase 2 trials.
John Kastelein“But the drug actually does much more than just lowering LDL, and one of the prime examples of that is lowering of Lp(a),” NewAmsterdam’s founder and chief scientific officer John Kastelein told Endpoints News ahead of Tuesday’s readout.
Obicetrapib is in multiple Phase 3 trials, two of which are expected to read out this year. NewAmsterdam is already thinking about launch plans. In February, the company raised $190 million in a public offering to support “the continued development and ongoing commercial readiness of obicetrapib.”
Amgen acquired the drug in 2015 as part of its buyout of Dezima Pharma, but it shelved the therapy two years later. NewAmsterdam saw potential in the drug, buying it for an undisclosed sum in 2020, and then refocusing the trials from boosting “good” HDL to lowering “bad” LDL.