NewAmsterdam Pharma Reports Positive Phase 3 Trial Results for Obicetrapib in Cardiovascular Disease Patients

NewAmsterdam Pharma Company N.V., a clinical biopharmaceutical firm known for developing oral, non-statin medications, has announced promising results from its Phase 3 BROADWAY clinical trial focused on the drug obicetrapib. This study targeted adult patients with established atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH), whose LDL cholesterol levels remain inadequately managed despite the use of maximally tolerated lipid-lowering therapies.

Obicetrapib, the drug under investigation, achieved the primary endpoint by demonstrating a statistically significant reduction in LDL-C levels when compared to a placebo. By day 84 of the trial, patients receiving a 10 mg dose of obicetrapib experienced an average LDL-C reduction of 33%, as substantiated by the least-squares mean. The trial's results revealed a mean LDL-C decrease from -2% in the placebo group to -35% in the obicetrapib group, marking a 33% differential with a statistical significance of p<0.0001.

Additionally, the trial highlighted a 21% reduction in major adverse cardiovascular events (MACE) in favor of obicetrapib over the course of one year. This included assessments of death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization. Although MACE was not a primary or secondary endpoint of the trial, the observed reduction suggests potential benefits beyond LDL-C lowering.

The safety profile of obicetrapib was comparable to that of the placebo, indicating favorable tolerability. The study reported a treatment discontinuation rate of 11.1% for obicetrapib versus 12.4% for the placebo group. The incidence of treatment-emergent adverse events (TEAEs) in the obicetrapib group was 59.8%, slightly lower than the 60.9% observed in the placebo group. Serious adverse events also showed a slightly lower occurrence in the obicetrapib group compared to placebo.

A key aspect of this study was the examination of changes in various biomarkers, such as high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1). These changes were consistent with previous clinical trial data, further establishing the drug's potential efficacy.

NewAmsterdam Pharma's Chief Executive Officer, Michael Davidson, expressed optimism about obicetrapib's capacity to offer a novel therapeutic option that could work alongside statins to mitigate cardiovascular risks. Additionally, John Kastelein, Chief Scientific Officer, noted the unexpected magnitude of MACE reduction, which may hint at benefits beyond LDL-C lowering alone.

The BROADWAY trial was a pivotal study involving a 52-week, global, double-blind, placebo-controlled setup that included 2,530 randomized participants. The trial spanned multiple regions, including North America, Europe, Asia, and Australia, to assess the efficacy and safety of 10 mg obicetrapib. Participants included in the study had a mean baseline LDL-C of approximately 100 mg/dL, despite high-intensity statin use in a significant portion of the cohort.

The promising results from the BROADWAY trial suggest that obicetrapib could become a valuable treatment option for patients struggling to achieve LDL-C targets. If approved, this therapy could address a significant unmet need for effective LDL-C lowering medications in patients at risk of cardiovascular disease.

NewAmsterdam Pharma plans to present further findings from the trial at upcoming medical conferences and aims to publish the results in a leading medical journal. These efforts underscore the company's commitment to advancing treatment options for cardiovascular disease, with obicetrapib potentially playing a critical role in future therapeutic strategies.