NewAmsterdam Pharma pany N.V.(US:NAMS) Newsfilterยท2024-07-08 12:00Core Insights - NewAmsterdam Pharma has completed enrollment in the pivotal Phase 3 TANDEM trial, which is a significant milestone in the development of obicetrapib, a CETP inhibitor aimed at treating dyslipidemia [1][6] - The company is encouraged by positive enrollment trends in four ongoing pivotal Phase 3 studies, indicating strong interest from physicians and patients [1][2] - The TANDEM trial aims to evaluate the fixed-dose combination of obicetrapib and ezetimibe in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [6][7] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin therapies for patients at risk of cardiovascular disease with elevated LDL-C levels [3][10] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [3] Clinical Trials - The TANDEM trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, evaluating the effect of a fixed-dose combination of obicetrapib and ezetimibe on LDL-C levels [7] - The trial's primary objective is to compare the LDL-C lowering effects of the combination therapy against monotherapy and placebo [7] - NewAmsterdam is also conducting two other pivotal Phase 3 trials, BROADWAY and BROOKLYN, to assess obicetrapib as a monotherapy and in combination with other lipid-lowering therapies [2][6] Market Potential - Cardiovascular disease remains a significant global health issue, with many patients unable to achieve target LDL-C levels despite existing therapies [2] - Obicetrapib has shown promise in previous Phase 2 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [2][6] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, which could influence its market positioning [1]