NewAmsterdam Pharma Enrolls Over 9,000 Patients in Pivotal Phase 3 PREVAIL Global Cardiovascular Outcome Trial Evaluating the Effect of Obicetrapib in Patients with Established Atherosclerotic Cardiovascular Disease - Seite 2

“Cardiovascular disease is one of the most common causes of death and disability globally,” said Stephen Nicholls, M.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University, and primary investigator on the Phase 3 PREVAIL trial. “Despite widespread availability of statin therapies, CVD-related deaths are on the rise, and many patients are not at their risk-based LDL-C goals. Based on clinical data to-date, we believe obicetrapib can meaningfully improve a range of lipid and lipoprotein measurements associated with CVD risk, which could translate into improved long-term outcomes for those patients. I am delighted to partner with the NewAmsterdam team to execute PREVAIL, a well-designed CVOT, and look forward to topline data on obicetrapib’s MACE benefit.”

“With obicetrapib, we aim to transform the care and treatment of cardiovascular disease, by designing a convenient, once-daily, low dose medicine that has the potential to help patients control their LDL-C levels and, ultimately, avoid catastrophic outcomes, if approved” added John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “With the PREVAIL CVOT enrollment target met and topline data from BROOKLYN and BROADWAY expected in the third and fourth quarter of 2024, respectively, and TANDEM in the first quarter of 2025, we look forward to executing our ongoing programs and to sharing our first pivotal datasets in the months ahead.”

About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company’s Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company’s Phase 2 ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo, including no increase in blood pressure or muscle related side effects. Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels (“dyslipidemia”) in NewAmsterdam’s clinical trials to date. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022, in BROOKLYN in July 2022, and in TANDEM in March 2024; completing enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.