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NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors
NewAmsterdam Pharma pany N.V.NewAmsterdam Pharma pany N.V.(US:NAMS) GlobeNewswire News Roomยท2024-07-08 12:00

Core Insights - NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 TANDEM clinical trial for obicetrapib plus ezetimibe, targeting patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [1][2] - The trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, aiming to evaluate the efficacy of the fixed-dose combination in lowering LDL-C levels compared to monotherapy and placebo [2][4] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, reflecting a positive trend in physician and patient interest in their clinical trials [2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease, particularly those with elevated LDL-C levels [1][5] - The company is conducting multiple Phase 3 trials, including BROADWAY, BROOKLYN, and PREVAIL, to assess the efficacy of obicetrapib as a monotherapy and in combination with ezetimibe [4][6] - Obicetrapib is a novel, low-dose CETP inhibitor designed to provide a safe and effective LDL-lowering therapy for patients who do not respond adequately to existing treatments [4][6]