NewAmsterdam Pharma announces data from Phase 3 BROOKLYN trial

NewAmsterdam Pharma announced topline data from the Company’s Phase 3 BROOKLYN clinical trial. BROOKLYN, the first of four studies in NewAmsterdam’s pivotal clinical development program, was designed to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36.3%. compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5%. The observed reductions in other biomarkers, including high-density lipoprotein cholesterol, non-HDL-C, lipoprotein and apolipoprotein B, met statistical significance and were consistent with data reported from the Company’s prior clinical trials. In the trial, obicetrapib was observed to be 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. NewAmsterdam plans to present full results from BROOKLYN at an upcoming medical conference and to publish the data in a major medical journal.