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.
Patients received a combination therapy of 10mg of obicetrapib or a placebo for 12 weeks. The combination of obicetrapib and ezetimibe resulted in the lowering of low-density lipoprotein cholesterol (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. Obicetrapib is in the pipeline for dyslipidaemia and is expected to launch in 2028 in the US, EU, and Japan, and is expected to reach $619m in sales by 2029.
Obicetrapib is an oral cholesterylester transfer protein (CETP) inhibitor developed to decrease LDL-C and increase high-density lipoprotein cholesterol (HDL-C) and the number of ApoA1-containing lipoprotein. This study demonstrated the efficacy of obicetrapib in combination with ezetimibe resulting in the reduction of LDL-C, non-HDL-C, Apo B, and total and small LDL particle concentrations while increasing HDL-C compared with high-intensity statin monotherapy. NewAmsterdam Pharma is conducting two Phase III pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies.
The main advantages of the combination therapy are enhanced cholesterol reduction, synergistic effects, and targeting different aspects of cholesterol metabolism. This study shows the potential of obicetrapib to be the first CETP inhibitor to advance to clinical practice and to be used in patients who are unable to achieve sufficient LDL-cholesterol lowering with other available lipid-lowering medications.
Likelihood of Approval and Phase Transition Success Rate Model – (Ezetimibe + Obicetrapib) in Hypercholesterolemia
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