NewAmsterdam Pharma Co N.V. (NAMS)

The company is a late-stage biopharmaceutical company focused on cardiometabolic diseases, specifically patients for whom approved therapies have not been adequate or well tolerated. It is developing obicetrapib, an oral, low-dose, once-daily, highly selective cholesterol ester transfer protein (CETP) inhibitor. The drug is intended to lower LDL cholesterol (LDL-C) as an adjunct to statin therapy in patients at risk of cardiovascular disease with elevated LDL-C. The company also believes CETP inhibition may play a role in other conditions, such as Alzheimer's disease and diabetes.

Obicetrapib is being developed both as a monotherapy and as a fixed-dose combination with ezetimibe. The company has not yet reported marketing approval for either. Its Phase 3 program includes BROADWAY and BROOKLYN (monotherapy on top of high-intensity statins), TANDEM (the ezetimibe combination), and PREVAIL, a cardiovascular outcomes trial in at least 9,000 patients with completion expected by the end of 2026. BROOKLYN and BROADWAY reported topline results in July and December 2024, and TANDEM in November 2024. Each met its primary endpoint, with safety and tolerability comparable to placebo. Mean LDL-C reductions versus placebo were 33% and 36% for the monotherapy trials and 52% for the combination. Earlier Phase 2 trials, a Phase 2a study in early Alzheimer's patients carrying the ApoE4 variant, and plans for preclinical diabetes work round out the pipeline. The company also reports reductions in lipoprotein(a), ApoB and small LDL particles, and says it is evaluating acquisitions or licenses of new candidates.

The target patients have atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia with elevated LDL-C despite optimal lipid-lowering therapy. The company estimates about 30 million U.S. patients are above their risk-based LDL-C goals despite treatment, including about 13 million with ASCVD. It notes that existing non-statin options such as ezetimibe, bempedoic acid and injectable PCSK9 inhibitors are limited by efficacy, route of administration, market access or side effects. It plans to seek approval in the United States, the EU, Japan, China and the United Kingdom, with clinical plans reflecting feedback from the FDA, EMA, Japan's PMDA and China's NMPA. If approved, it intends to commercialize in the United States itself and to consider partners for other regions such as Japan and China.

The company has partnered with Menarini, which holds exclusive rights to commercialize obicetrapib 10 mg, alone or combined with ezetimibe, in most European countries if approved. It may use other collaboration, license, distribution or monetization arrangements in the future. It is led by CEO Dr. Michael Davidson and founder and Chief Scientific Officer Dr. John Kastelein, and is backed by investors including Frazier Life Sciences, Bain Capital, Forbion, RA Capital and Viking Global. The text does not describe its manufacturing, suppliers or headquarters.