On Tuesday, NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS ) revealed topline data from its Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy .
ASCVD is a chronic disease that occurs when plaque builds up in the walls of arteries, narrowing them and reducing blood flow. HeFH is a genetic disorder that causes high cholesterol levels from birth.
Also Read: NewAmsterdam Pharma’s Cholesterol Drug To See Blockbuster Sales, Bullish Analyst Sees Massive Upside
Low-density lipoprotein cholesterol (LDL-C) measures the amount of LDL cholesterol in the blood and is often called “bad” cholesterol.
The primary endpoint was the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo.
The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001).
As part of the safety analysis, the trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization. In addition, a 21% reduction in MACE favoring obicetrapib was observed.
William Blair writes, “This level of MACE benefit increases our confidence in the ability of obicetrapib to demonstrate a greater than 20% relative risk reduction on the primary endpoint of MACE, in the ongoing Phase III (PREVAIL) cardiovascular outcomes study.”
The observed changes in other biomarkers were consistent with data reported in the company’s prior clinical trials.
Overall, obicetrapib was also observed to be well-tolerated, with safety results, including blood pressure, comparable to the placebo.
The treatment discontinuation rate for the obicetrapib arm was 11.1% versus 12.4% for the placebo.
Price Action: NAMS stock is up 33.6% at $24.74 at last check Tuesday.
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