NewAmsterdam: Enrollment met for 3 Prevail outcomes trial for ASCVD

NewAmsterdam Pharma Company announced that it has met the enrollment target of 9,000 patients for the pivotal Phase 3 PREVAIL cardiovascular outcomes trial 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 . 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.”