Topline results from ROSE2 study of obicetrapib + ezetimibe as 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 III safety and efficacy trial.

ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase II 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. NewAmsterdam anticipates sharing full data from this Phase II clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.

The Company began enrolling patients in Phase III BROADWAY in January 2022 and in BROOKLYN in July 2022. The Company also commenced its Phase III PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.