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About NewAmsterdam Pharma
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to transforming patient care in the field of cardiovascular disease (CVD). With a focus on populations where existing therapies are insufficient or poorly tolerated, NewAmsterdam aims to address significant unmet medical needs through innovative, non-statin LDL-C lowering treatments.
Core Product: Obicetrapib
At the heart of NewAmsterdam’s development pipeline is obicetrapib, a next-generation, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor. Designed to overcome the limitations of current LDL-C lowering therapies, obicetrapib offers a once-daily, highly selective treatment option. It is being developed both as a monotherapy and in a fixed-dose combination with ezetimibe, targeting patients at risk of CVD who struggle to achieve LDL-C goals despite maximally tolerated statins or other lipid-lowering therapies.
Clinical Development Program
NewAmsterdam is conducting a comprehensive Phase 3 clinical development program involving over 12,250 patients worldwide. Key trials include:
- BROADWAY: Evaluates obicetrapib monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
- BROOKLYN: Focuses on LDL-C reduction in HeFH patients on maximally tolerated lipid-lowering therapy.
- TANDEM: Assesses the fixed-dose combination of obicetrapib and ezetimibe for LDL-C lowering in ASCVD and HeFH patients.
- PREVAIL: A cardiovascular outcomes trial (CVOT) designed to evaluate obicetrapib’s ability to reduce major adverse cardiovascular events (MACE).
These trials have demonstrated statistically significant LDL-C reductions and a safety profile comparable to placebo, positioning obicetrapib as a promising alternative for patients with limited options.
Market Position and Differentiation
NewAmsterdam operates in the highly competitive cardiovascular treatment market, which includes statins, PCSK9 inhibitors, and other lipid-lowering therapies. The company differentiates itself through its focus on CETP inhibition, offering a novel mechanism of action that addresses residual cardiovascular risk factors beyond LDL-C reduction, such as lipoprotein(a) and small LDL particles.
With robust intellectual property protection extending until 2043 and exclusive European commercialization rights granted to the Menarini Group, NewAmsterdam is strategically positioned to capture a significant share of the LDL-C lowering market.
Addressing Unmet Needs in CVD
Cardiovascular disease remains the leading cause of death globally, with millions of patients failing to achieve LDL-C targets despite available therapies. NewAmsterdam aims to bridge this gap by offering a safe, effective, and convenient oral treatment option. Obicetrapib’s potential to reduce LDL-C and improve cardiovascular outcomes could transform the treatment landscape for patients with ASCVD, HeFH, and other high-risk conditions.
Commitment to Innovation and Patient Care
NewAmsterdam’s mission is underpinned by a commitment to rigorous clinical research, operational excellence, and patient-centric innovation. By addressing critical gaps in CVD treatment, the company seeks to improve health outcomes for millions of patients worldwide.
NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 BROOKLYN clinical trial for obicetrapib, targeting adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels are inadequately managed despite maximal lipid-lowering therapy. The trial enrolled 354 participants across ten countries, with results expected in the second half of 2024. Obicetrapib, a next-generation CETP inhibitor, aims to offer improved options for HeFH patients. Previous Phase 2 trials showed significant LDL-C reduction of 51% and 59% in combination therapy. The rapid enrollment reflects a pressing unmet need for effective LDL-C management in the HeFH community.
FAQ
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