Menarini Group announces Positive Topline Data from Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials Evaluating Obicetrapib and the Fixed-Dose Combination Obicetrapib with Ezetimibe 10 mg

Core Insights - Menarini Group announced positive topline data from Phase 3 BROADWAY and TANDEM clinical trials, demonstrating the efficacy of Obicetrapib in reducing LDL-C levels significantly [1][17] - Obicetrapib achieved a 33% reduction in LDL-C compared to placebo in the BROADWAY trial, with a high statistical significance (p<0.0001) [4][15] - The fixed-dose combination of Obicetrapib and Ezetimibe in the TANDEM trial resulted in a 48.6% reduction in LDL-C compared to placebo, also with high statistical significance (p<0.0001) [10][11] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][20] - The Menarini Group is an international pharmaceutical and diagnostics company with a turnover of $4.7 billion, focusing on therapeutic areas with high unmet needs [19] Clinical Trial Details - The BROADWAY trial involved 2,530 patients with established ASCVD and/or HeFH, evaluating the efficacy of 10 mg Obicetrapib as an adjunct to maximally tolerated lipid-lowering therapies [14][17] - The TANDEM trial included 407 patients and assessed the fixed-dose combination of Obicetrapib and Ezetimibe against monotherapy and placebo [16][17] Safety and Tolerability - Both BROADWAY and TANDEM trials reported that Obicetrapib was well tolerated, with safety profiles comparable to placebo [5][10] - The treatment discontinuation rates were 11.1% for Obicetrapib and 12.4% for placebo in the BROADWAY trial, indicating similar tolerability [7] Market Implications - The positive results from these trials may provide new treatment options for patients who do not achieve LDL-C targets with existing therapies, addressing a significant unmet need in cardiovascular care [13][20] - The development of Obicetrapib aligns with the growing demand for effective LDL-lowering therapies, particularly in populations with high cardiovascular risk [18][20]