Menarini announces topline data from Phase 3 BROADAY, TANDEM trials

Menarini Group announces positive topline data from the Phase 3 BROADWAY and the Phase 3 TANDEM clinical trials sponsored by NewAmsterdam Pharma (NAMS) Company, a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease, CVD, with elevated low-density lipoprotein cholesterol, for whom existing therapies are not sufficiently effective or well tolerated. Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies with high statistical significance. Approximately 50% of patients in BROADWAY and over 70% of patients in TANDEM achieved LDL-C target below 55 mg/dL. In BROADWAY a 21% reduction in major adverse cardiovascular events favoring Obicetrapib was observed at one year. In both studies, Obicetrapib monotherapy and the fixed dose combination with Ezetimibe were shown to be well tolerated.