NewAmsterdam Pharma Company N.V. announced the full results of 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. The data are being presented in an oral late-breaker presentation at the National Lipid Association (“NLA”) Scientific Sessions 2023 and will be published concurrently in the Journal of Clinical Lipidology. ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed.

Statistically significant improvements in lipoprotein(a) (“Lp(a)”), non-HDL cholesterol (“non-HDL-C”) and total and small LDL particles were also observed. In addition, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo. With these data in hand, the Company has selected a formulation for a fixed-dose combination tablet and intends to advance the compound into a Phase 3 trial in the first quarter of 2024.

ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase 2 clinical trial 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. Patients were randomized to receive combination therapy, obicetrapib 10 mg or placebo for a 12 week treatment period. A total of 119 patients enrolled in ROSE2, of which 97 were included in the on-treatment analysis.

Patients presented at baseline with a fasting LDL-C greater than 70 mg/dL and triglycerides (“TG”) less than 400 mg/dL and all were receiving a stable dose of high-intensity statin therapy.