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

Enrollment to continue to the end of April to accommodate strong patient and site interest

NAARDEN, the Netherlands and MIAMI, April 09, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it has met the enrollment target of 9,000 patients for the pivotal Phase 3 PREVAIL cardiovascular outcomes trial (“CVOT”) evaluating obicetrapib in adult patients with a history of atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.

“We are pleased to announce that our enrollment target has been met for our pivotal Phase 3 PREVAIL trial, marking a crucial milestone in NewAmsterdam’s mission to advance cardiovascular treatment for the millions of people who are failing to meet their risk-based LDL-C goals despite taking maximally tolerated lipid-lowering therapy,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “PREVAIL, our pivotal CVOT, will potentially demonstrate that obicetrapib’s lowering of LDL-C will reduce major adverse cardiac events (“MACE”). We expect data from PREVAIL will complement results from our ongoing pivotal Phase 3 trials, BROADWAY, BROOKLYN and TANDEM, and further support obicetrapib’s clinical profile as a well-tolerated and potentially highly effective option for treating hypercholesterolemia and preventing serious cardiovascular disease, if approved.”

The double-blind, placebo-controlled Phase 3 PREVAIL trial is now expected to randomize over 9,000 patients with ASCVD in over 500 sites across 23 countries including the United States, Canada, United Kingdom, Netherlands, Germany, Japan, China, Italy, and Australia. Patients enrolling in the study were required to have established ASCVD with LDL-C levels greater than 55 mg/dl, and an additional risk enhancer in participants with an LDL-C level below 100 mg/dl, despite taking maximally tolerated lipid-lowering therapy. Patients were randomized to receive placebo or 10 mg obicetrapib over a 30-month period. The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. Secondary objectives include evaluating the effect of obicetrapib on all-cause mortality, total CV events, new-onset diabetes mellitus, and change in LDL-C, non-high-density lipoprotein cholesterol, and apolipoprotein B levels.