NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) has released positive topline data from its pivotal phase 3 Brooklyn clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH). The trial achieved its primary endpoint of LS mean reduction in low-density lipoprotein cholesterol (LDL-C) on top of maximally tolerated lipid-modifying therapies at day 84 with a statistically significant reduction (p<0.0001), which was sustained at day 365 (p<0.0001). Obicetrapib lowered LDL-C by 36.3% at day 84 and 41.5% at day 365, compared to placebo.
The trial demonstrated that obicetrapib was generally well-tolerated, with safety results comparable to placebo and no increase in blood pressure. The treatment discontinuation rate for the obicetrapib arm was 7.6% versus 14.4% for placebo.
In terms of adverse events, the incidence of treatment-emergent adverse events, study-drug related adverse events, and treatment-emergent serious adverse events were all lower in the obicetrapib arm compared to placebo. Additionally, the observed reductions in other biomarkers, including high-density lipoprotein cholesterol, non-HDL-C, lipoprotein(a), and apolipoprotein B, met statistical significance and were consistent with data reported from the company’s prior clinical trials.
The pivotal phase 3 Brooklyn clinical trial was a 52-week, global, randomized, double-blind, placebo-controlled multicenter study that evaluated the efficacy and safety of 10 mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with HeFH whose LDL-C is not adequately controlled.
NewAmsterdam's CEO, Michael Davidson, expressed excitement about the results from the Brooklyn trial and emphasized the potential of obicetrapib to significantly reduce LDL-C in a challenging patient population over a duration of one year. He also highlighted that adverse events and discontinuations due to side effects were similar to placebo, consistent with observations from phase 2 studies.
The company plans to present full results from the Brooklyn trial at an upcoming medical conference and to publish the data in a major medical journal.
Obicetrapib is part of NewAmsterdam’s global pivotal phase 3 program, which consists of four studies in over 12,250 patients, including the Brooklyn trial, and upcoming trials such as Broadway and Tandem.
The market has reacted to these announcements by moving the company's shares -9.0% to a price of $17.17. For the full picture, make sure to review NewAmsterdam Pharma's 8-K report.
