NewAmsterdam Pharma Company N.V. 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 ("CETP") 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. ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase 2 study to evaluate the efficacy, safety and tolerability of obicetrapib 10 mg in combination with ezetimibe 10 mg as an adjunct to high- intensity statin therapy.

A total of 119 patients were randomized to receive combination therapy, obicetrapib 10 mg or placebo for an 84-day treatment period. The primary efficacy endpoint was the percent change from Day 1 to Day 84 in LDL-C for the combination treatment group compared to the placebo group and was met. Patients treated with the combination of obicetrapib and ezetimibe achieved a median reduction in LDL-C of 59%, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 6%.

Overall, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo.