NewAmsterdam announces results from obicetrapib /ezetimibe combo trial

NewAmsterdam Pharma announced topline results from ROSE2, a Phase 2 clinical trial evaluating obicetrapib, the company’s oral, low-dose and once-daily cholesteryl ester transfer protein inhibitor, in combination with ezetimibe as an adjunct to high-intensity statin therapy. Based on the encouraging results observed, NewAmsterdam is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe, a non-statin oral LDL-lowering therapy, to be tested in a definitive bioequivalence trial and a Phase 3 safety and efficacy trial."Elevated levels of LDL cholesterol remain a significant public health burden despite the availability of statins. While a range of adjunctive treatments are available, many patients are not able to benefit because these agents either do not sufficiently lower LDL-C or are too expensive," said Christie Ballantyne, M.D., Chief of Cardiovascular Research and Professor at Baylor College of Medicine. "Today, patients – especially those at high-risk – are typically treated with very high-dose statin therapy, which can be associated with intolerable side effects that limit adherence. Combination regimens comprising low-dose statin therapy plus another LDL-C lowering agent, such as a fixed-dose combination of obicetrapib and ezetimibe, may become a powerful strategy to deliver patients better outcomes, while also increasing their willingness and ability to remain on therapy."