Obicetrapib Trial Enlists 9,000+ for Phase 3 Cardiovascular Study

NewAmsterdam Pharma, a biopharmaceutical firm, has achieved a significant milestone in its Phase 3 PREVAIL trial, reaching its target of enrolling 9,000 patients. The study is focused on evaluating the effects of obicetrapib, an oral, non-statin medication, on adults with atherosclerergic cardiovascular disease whose low-density lipoprotein cholesterol (LDL-C) levels are not adequately managed by existing treatments. The trial's extension will run through April, with the aim to randomize over 9,000 participants.

Michael Davidson, CEO of NewAmsterdam, expressed satisfaction with the trial's progress, highlighting the company's commitment to improving cardiovascular care for those not meeting LDL-C goals despite current therapies. The PREVAIL trial is anticipated to show that obicetrapib can reduce major adverse cardiac events (MACE). The findings are expected to support the drug's profile as a well-tolerated and effective treatment for hypercholesterolemia and cardiovascular disease prevention.

The PREVAIL trial is a double-blind, placebo-controlled study that will involve over 9,000 patients with established atherosclerergic cardiovascular disease across 500 sites in 23 countries. Participants are required to have LDL-C levels exceeding 55 mg/dl, with an additional risk enhancer for those below 100 mg/dl, even while on maximally tolerated lipid-lowering therapy. The trial will compare the effects of a placebo versus 10 mg of obicetrapib over a 30-month period, with the primary goal being the impact on MACE, which includes cardiovascular death, myocardial infarction, stroke, and non-elective coronary revascularization.

Stephen Nicholls, Director of the Monash Victorian Heart Institute and a primary investigator of the PREVAIL trial, emphasized the global prevalence of cardiovascular disease and the rising trend of CVD-related deaths despite statin availability. He believes obicetrapib has the potential to improve lipid and lipoprotein measurements linked to CVD risk, potentially leading to better long-term outcomes for patients.

John Kastelein, Chief Scientific Officer at NewAmsterdam, added that the company aims to revolutionize cardiovascular care with a convenient, once-daily, low-dose medication that could help control LDL-C levels and prevent severe outcomes. With the enrollment target for the PREVAIL trial met, the company looks forward to sharing pivotal data in the coming months.

Obicetrapib is a novel CETP inhibitor being developed by NewAmsterdam to address the limitations of current LDL-lowering treatments. In previous trials, obicetrapib has shown significant LDL-C reduction with a side effect profile similar to placebo, including no increase in blood pressure or muscle-related side effects. The company is also conducting other Phase 3 trials, BROADWAY, BROOKLYN, and TANDEM, to evaluate obicetrapib's efficacy as monotherapy or in combination with ezetimibe.

NewAmsterdam Pharma is dedicated to enhancing patient care for those with metabolic diseases where current therapies fall short. The company is conducting multiple phase 3 studies to investigate obicetrapib as a preferred LDL-C lowering therapy for patients at risk of cardiovascular disease with elevated LDL-C levels.