NewAmsterdam Pharma presented positive data from its Phase II ROSE2 trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy at the National Lipid Association (NLA) Scientific Sessions 2023. The study demonstrated the efficacy of obicetrapib in combination with ezetimibe resulting in the reduction of low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-(HDL-C), Apo B, and total and small LDL particle concentrations, while increasing HDL-C compared with high-intensity statin monotherapy. This suggests that obicetrapib has the potential to become the first cholesteryl ester transfer protein (CETP) inhibitor to advance to clinical practice, says GlobalData, a leading data and analytics company.

According to GlobalData, obicetrapib is in the pipeline for dyslipidaemia and is expected to launch in 2028 in the US, EU, and Japan. It is expected to reach $619 million in sales by 2029.  Obicetrapib is an oral CETP inhibitor developed to decrease LDL-C and increase HDL-C and the number of ApoA1-containing lipoprotein.

Dr Shireen Mohammad, Cardiovascular & Metabolic Disorders Analyst at GlobalData, comments: “Obicetrapib has shown promising results in the ROSE2 trials of the effectiveness of obicetrapib in combination with ezetimibe. This suggests that obicetrapib has the potential to be used in patients who are unable to achieve sufficient LDL-cholesterol lowering with other available lipid-lowering medications.”

In the Phase II ROSE2 trial, patients received a combination therapy of 10mg of obicetrapib or placebo for 12 weeks. The combination of obicetrapib and ezetimibe resulted in the lowering of LDL-C levels in 88% of patients to less than 55mg/dL. At 12 weeks, LDL-C was reduced by 43.5%, while obicetrapib in combination with ezetimibe reduced LDL-C levels by 63.4%. Furthermore, a median reduction in lipoprotein (a) of 47.2% and 40.2% in the monotherapy and combination, respectively, was observed.

Mohammad concludes: “The main advantages of combination therapy are enhanced cholesterol reduction, synergistic effects, and targeting different aspects of cholesterol metabolism. NewAmsterdam is conducting two Phase III pivotal trails, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies.”