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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a leading late-stage biopharmaceutical company headquartered in the Netherlands, dedicated to revolutionizing patient care for metabolic diseases. The company focuses on populations where existing therapies are insufficient or poorly tolerated. Central to NewAmsterdam's innovation is obicetrapib, a next-generation, oral, low-dose CETP inhibitor designed to address limitations of current LDL-C lowering treatments.
As of 2024, NewAmsterdam is at the forefront of clinical development, with multiple pivotal Phase 3 trials underway. The company is optimistic about its potential to transform cardiovascular disease (CVD) treatment. Recent milestones include the enrollment completion of the BROOKLYN and BROADWAY Phase 3 trials, both aimed at evaluating obicetrapib’s efficacy as an adjunct to maximally tolerated statin therapy. Additionally, the company's PREVAIL cardiovascular outcomes trial and the newly initiated TANDEM Phase 3 trial are progressing, assessing obicetrapib's combination with ezetimibe for patients with elevated LDL-C levels.
In 2023, NewAmsterdam reported promising outcomes from its Phase 2 trials, including the ROSE2 trial, which combined obicetrapib with ezetimibe, demonstrating a significant 63% reduction in LDL-C levels. The company's robust clinical pipeline showcases obicetrapib’s strong tolerability profile, having tested the drug in over 800 patients with elevated lipid levels and observing statistically significant results without severe adverse events.
Looking to the future, NewAmsterdam is well-positioned financially, forecasting sufficient cash runway through 2026 to support its ambitious development plans. The company is also actively preparing for the global launch of obicetrapib, pending necessary regulatory approvals. This includes strategic investments in its commercial organization to ensure comprehensive market readiness.
NewAmsterdam’s commitment to innovation is further reinforced by strong intellectual property protection for obicetrapib, with patents extending until July 2043. This robust IP portfolio underscores the company's dedication to maintaining a competitive edge in the biopharmaceutical industry.
For more information, visit NewAmsterdam Pharma Company’s investor relations page or contact their media and investor relations teams for the latest updates.
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.
NewAmsterdam Pharma Company (Nasdaq: NAMS) has announced the appointment of Janneke van der Kamp as an independent director on its Board of Directors. Ms. van der Kamp brings over two decades of pharmaceutical experience, particularly in cardiovascular disease. CEO Michael Davidson expressed optimism about her contributions as the company advances its clinical trials for obicetrapib. The company, focused on transforming therapies for metabolic diseases, is preparing for key regulatory milestones, building on promising clinical results showing significant LDL-C reductions with obicetrapib. NewAmsterdam recently completed a business combination with Frazier Lifesciences, raising approximately $328 million.
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