NewAmsterdam’s drug shows promise in lowering LDL-C

NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS), a clinical-stage biopharmaceutical firm, saw its shares surge 62% after announcing positive results from its Phase 3 BROADWAY clinical trial. The trial evaluated the efficacy of obicetrapib, an oral, non-statin cholesterol-lowering medication, in patients with cardiovascular disease and high low-density lipoprotein cholesterol (LDL-C) levels.

The primary endpoint of the trial, a statistically significant reduction in LDL-C levels at day 84, was achieved with a 33% decrease compared to placebo. Additionally, a 21% reduction in major adverse cardiovascular events (MACE) was observed at one year, although MACE was not a primary or secondary endpoint of the trial.

The safety profile of obicetrapib was comparable to placebo, with a well-tolerated administration and safety results in line with expectations. The treatment discontinuation rate for the obicetrapib arm was slightly lower than that of the placebo.

Dr. Michael Davidson, CEO of NewAmsterdam, expressed pride in the trial’s findings, which not only confirmed the efficacy and tolerability observed in Phase 2 but also suggested a differentiated safety and clinical profile for obicetrapib. Dr. John Kastelein, Chief Scientific Officer, highlighted the clean safety profile and the potential benefits of obicetrapib beyond LDL-C lowering.

The BROADWAY trial was a 52-week, global, randomized, double-blind, placebo-controlled multicenter trial, which enrolled over 2,500 patients. The trial aimed to evaluate obicetrapib as an adjunct to maximally tolerated lipid-lowering therapies in patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).

NewAmsterdam plans to present additional BROADWAY results at an upcoming medical conference and publish the data in a major medical journal. The company also intends to discuss regulatory filings for obicetrapib with authorities, aiming to address the global need for effective LDL-C lowering therapies.

The announcement was made based on a press release statement from NewAmsterdam Pharma Company.

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