NewAmsterdam Pharma announced positive topline data from its Phase 3 BROADWAY clinical trial, evaluating obicetrapib in adult patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). The trial achieved its primary endpoint, demonstrating a statistically significant LDL-C reduction of 33% (p<0.0001) at day 84 compared to placebo.
An exploratory analysis within the trial revealed a 21% reduction in major adverse cardiovascular events (MACE) favoring obicetrapib at one year. This MACE reduction, while an exploratory endpoint, suggests a potential benefit beyond LDL-C lowering and could be a significant differentiator for obicetrapib.
Obicetrapib was observed to be well-tolerated, with safety results comparable to placebo, including blood pressure. The treatment discontinuation rate for the obicetrapib arm was 11.1% versus 12.4% for placebo, reinforcing its favorable safety profile.
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