NewAmsterdam Pharma Co N.V.

NewAmsterdam Pharma Co N.V. is a late-stage biopharmaceutical company focused on improving patient care for cardiometabolic diseases where current therapies are insufficient or not well tolerated. The company aims to address the need for a safe, well-tolerated, and convenient therapy to lower low-density lipoprotein cholesterol (LDL-C). Its primary product candidate is obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (CETP) inhibitor. NewAmsterdam Pharma is developing obicetrapib, both alone and as a fixed-dose combination (FDC) with ezetimibe, as an adjunct to statin therapy for patients at risk of cardiovascular disease (CVD) with elevated LDL-C, for whom existing treatments are not effective enough or well tolerated. The company also believes that CETP inhibition might help mitigate the risk of developing other diseases, such as Alzheimer's disease. In its Phase 3 clinical trials, BROADWAY and BROOKLYN, obicetrapib as an adjunct to high-intensity statin therapy met its primary and secondary endpoints, showing statistically significant reductions in LDL-C. In the Phase 3 TANDEM clinical trial, obicetrapib combined with ezetimibe as an adjunct to high-intensity statin therapy also met its primary and secondary endpoints, with statistically significant reductions in LDL-C. Statistically significant LDL-C lowering was also observed in five Phase 2 clinical trials: TULIP, ROSE, OCEAN, ROSE2, and a Japan Phase 2b clinical trial, where obicetrapib was evaluated as a monotherapy or in combination with ezetimibe 10 mg. In these trials, side effects, including muscle-related side effects and drug-related treatment-emergent serious adverse events (TESAEs), were similar in frequency and severity to placebo.