NewAmsterdam Pharma Company N.V., a clinical-stage biopharmaceutical company, has announced its strategic priorities for 2024, emphasizing the development of obicetrapib, an oral, low-dose, and once-daily cholesteryl ester transfer protein (CETP) inhibitor. The company is positioned for three Phase 3 trial readouts over the next 18 months, with topline data expected from the Phase 3 BROOKLYN trial in heterozygous familial hypercholesterolemia (HeFH) in the third quarter of 2024 and the BROADWAY trial in atherosclerotic cardiovascular disease (ASCVD) in the fourth quarter of 2024. Additionally, NewAmsterdam plans to initiate TANDEM, a pivotal Phase 3 trial evaluating a fixed-dose combination of obicetrapib and ezetimibe, in the first quarter of 2024, with topline data expected in the first quarter of 2025.
Obicetrapib is being developed as the preferred LDL-C lowering therapy to be used alongside maximally tolerated statin therapy for high-risk CVD patients. The company has reported positive data from Phase 2 clinical trials, demonstrating significant LDL-lowering effects with generally moderate side effects. NewAmsterdam is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, BROADWAY, and PREVAIL, with plans to initiate a fourth trial, TANDEM.
The BROOKLYN trial focuses on patients with HeFH, aiming to evaluate the effect of obicetrapib on LDL-C levels and other lipid parameters. The BROADWAY trial targets adult patients with HeFH and/or established ASCVD, assessing the impact of obicetrapib on LDL-C levels and other secondary objectives. The PREVAIL trial is a cardiovascular outcomes trial designed to evaluate the effect of obicetrapib on the risk of major adverse cardiovascular events in patients with a history of ASCVD.
NewAmsterdam is well-capitalized, with sufficient cash to support operations through the anticipated readouts of its ongoing Phase 3 trials. The company's comprehensive Phase 3 program aims to demonstrate obicetrapib's potential to help patients achieve guideline-mandated LDL-C goals, thereby reducing the risk of major adverse cardiac events and providing physicians with multiple treatment options to optimize patient care.
