NAARDEN, Netherlands– NewAmsterdam Pharma (NAP), a clinical-stage company focused on the research and development of transformative therapies for cardiometabolic diseases, today announced dose administration for the first patient in ROSE2, the Company’s Phase 2 trial of obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor. ROSE2 is 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 and as monotherapy, in each case as an adjunct to high-intensity statin therapy. Ezetimibe is a cholesterol absorption inhibitor that works by partially blocking the absorption of cholesterol in the small intestine, causing the upregulation of low-density lipoprotein (LDL) receptors – a mechanism of action that NewAmsterdam believes could be additive and potentially synergistic with CETP inhibition for reducing levels of low-density lipoprotein cholesterol (LDL-c).
“Building off the positive data from our Phase 2 ROSE study presented at the American Heart Association’s (AHA) Scientific Sessions in November 2021, we are excited about ROSE2’s potential to show the effectiveness of combining obicetrapib with ezetimibe in reducing LDL-c. NewAmsterdam is developing a fixed-dose combination of these two drugs as a single, once-daily, low-dose oral pill, which we hope will become an exceptionally potent option for patients needing further LDL-C reduction,” said Dr. Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma. “There is still a substantial unmet need for simple, well-tolerated, oral, low-dose therapy options for patients at high risk for cardiovascular disease who are unable to meet their current lipid management goals. We look forward to advancing our development program with the addition of the ROSE2 study alongside our two Phase 3 programs, BROADWAY and PREVAIL, to help find a solution for this unmet need.”
Participants will be randomized to receive combination therapy (i.e., obicetrapib 10 mg + ezetimibe 10 mg), obicetrapib monotherapy (obicetrapib 10 mg), or placebo. The primary objective of the ROSE2 trial is to evaluate the efficacy endpoint, which is the percent change from Day 1 to Day 84 in LDL-c for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group.
A total of 108 patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10mg obicetrapib + 10mg ezetimibe combination therapy, dosed as a once-daily oral treatment for an 84-day treatment period.
