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NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia

april 24, 2023

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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-density lipoprotein cholesterol (“non-HDL-C”), apolipoprotein B (“ApoB”), and lipoprotein (a). The trial is also evaluating the safety and tolerability profile of obicetrapib.

“We are delighted to complete enrollment in the Phase 3 BROOKLYN trial several months ahead of schedule,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We believe the rapid enrollment of this study is a reflection of the deep unmet need in the HeFH community for a potent and well-tolerated oral tablet as an adjunct to maximally tolerated statin therapy, especially for this group of patients who spend most of their lives, some from a young age, taking LDL-lowering therapy. We would like to thank the principal investigators at clinical trial sites worldwide for their significant contributions, and for their trust and belief in obicetrapib as a new medicine with the potential to improve outcomes for patients living with HeFH whose LDL-C levels are not adequately controlled with standard of care. We look forward to continued partnership as we execute the BROOKLYN trial and work to establish obicetrapib as the ideal complement to statin therapy.”

Media Contact

Spectrum Science on behalf of NewAmsterdam
Bryan Blatstein
P: 917-714-2609
bblatstein@spectrumscience.com

Investor Contact

Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1 212-362-1200
hannah.deresiewicz@sternir.com