NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia

Core Insights - NewAmsterdam Pharma announced positive topline data from the Phase 3 BROOKLYN clinical trial, demonstrating significant LDL-C reduction in patients with heterozygous familial hypercholesterolemia (HeFH) [1][2][11] Group 1: Clinical Trial Results - The BROOKLYN trial achieved its primary endpoint with a statistically significant LS mean reduction in LDL-C of 36.3% at day 84 and 41.5% at day 365 compared to placebo (p < 0.0001) [2][3] - 51% of patients treated with obicetrapib achieved LDL-C levels below 70 mg/dL [3] - The treatment was well-tolerated, with a discontinuation rate of 7.6% for obicetrapib compared to 14.4% for placebo [4][5] Group 2: Safety and Tolerability - Safety results for obicetrapib were comparable to placebo, with no increase in blood pressure or significant differences in liver enzymes, hs-CRP, or renal function [5][12] - The incidence of treatment-emergent adverse events (TEAEs) was 63.7% for obicetrapib compared to 70.3% for placebo [4] Group 3: Future Developments - NewAmsterdam plans to present full results from the BROOKLYN trial at a medical conference and publish the data in a major medical journal [6] - The company is conducting additional pivotal trials, including BROADWAY and TANDEM, with topline data expected in late 2024 and early 2025, respectively [11][12] Group 4: Company Overview - NewAmsterdam Pharma focuses on developing oral, non-statin therapies for patients at risk of cardiovascular disease, particularly those with elevated LDL-C levels who have not responded adequately to existing treatments [1][13] - The company aims to address the unmet need for effective LDL-lowering therapies in populations with metabolic diseases [13]