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NewAmsterdam Announces Positive Results from ROSE2, Phase 2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy
-- Achieved primary endpoint with statistically significant reduction in LDL-C (p -- Median percent change in LDL-C of -59% in combination arm compared to -6%
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Achieved primary endpoint with statistically significant reduction in LDL-C (p -- Median percent change in LDL-C of -59% in combination arm compared to -6% in placebo arm ---- Favorable safety and tolerability ---- Data support advancement of fixed-dose combination into bioequivalence and Phase 3 safety and efficacy trials - NAARDEN, the Netherlands and MIAMI, Jan. 17, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq:NAMS) (“NewAmsterdam” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today announced topline results from 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. 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 3 safety and efficacy trial. “Elevated levels of LDL cholesterol (LDL-C) remain a significant public health burden despite the availability of statins. While a range of adjunctive treatments are available, many patients are not able to benefit because these agents either do not sufficiently lower LDL-C or are too expensive,” said Christie Ballantyne, M.D., Chief of Cardiovascular Research and Professor at Baylor College of Medicine. “Today, patients – especially those at high-risk – are typically treated with very high-dose statin therapy, which can be associated with intolerable side effects that limit adherence. Combination regimens comprising low-dose statin therapy plus another LDL-C lowering agent, such as a fixed-dose combination of obicetrapib and ezetimibe, may become a powerful strategy to deliver patients better outcomes, while also increasing their willingness and ability to remain on therapy.” Topline Data from the ROSE2 Trial “We are excited to announce topline data from ROSE2, which provide support for our belief that obicetrapib and ezetimibe have distinct, complementary mechanisms of action that, when synergized, have the potential to deliver positive outcomes for patients needing further LDL-C reduc...