Business
NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia
-- Enrollment Completed Several Months Ahead of Schedule, Reflecting Significant Unmet Need and Patient Demand for New Options ---- Topline Results Expected
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- Enrollment Completed Several Months Ahead of Schedule, Reflecting Significant Unmet Need and Patient Demand for New Options ---- Topline Results Expected in 2H 2024 – NAARDEN, the Netherlands and MIAMI, April 24, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today announced the completion of patient enrollment in the pivotal Phase 3 BROOKYLN clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”), whose low-density lipoprotein cholesterol (“LDL-C”) is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam expects to report topline results in the second half of 2024. “HeFH is a genetic condition resulting in a serious error of metabolism, in which patients present with elevated cholesterol levels from birth and, as a result, are at a very high risk of developing atherosclerotic cardiovascular disease (“ASCVD”),” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “Effective treatment requires early intervention aimed at lowering patients’ LDL-C levels before they suffer the consequences of high cholesterol, which can include damaged blood vessels, myocardial infarction, and premature death. We believe obicetrapib may offer a highly needed treatment for HeFH, with robust LDL-lowering activity and excellent tolerability observed to date, all in a convenient, oral formulation.” The double-blind, placebo-controlled Phase 3 BROOKLYN trial enrolled 354 patients with a history of HeFH across ten countries in North America, Europe, and Africa. The mean baseline LDL-C for enrolled patients is >120 mg/dL despite high intensity statin use reported by approximately 70% of patients during screening. Females comprise approximately 53% of the study population and the median age of participants at baseline is 57 years. Patients were randomized to receive placebo or 10 mg obicetrapib dosed as a once-daily oral treatment with or without food for 52 weeks. The primary objective is to evaluate the effect of obicetrapib on LDL-C levels. Secondary objectives include evaluating the effect of obicetrapib on non-high-den...