NewAmsterdam Pharma Finishes Enrollment for Phase 3 TANDEM Trial of Obicetrapib-Ezetimibe Combo in HeFH/ASCVD Patients

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a clinical-stage biopharmaceutical firm focusing on oral non-statin medications for cardiovascular disease patients with high LDL cholesterol, has announced the completion of patient enrollment for the Phase 3 TANDEM clinical trial. This trial evaluates a fixed-dose combination of obicetrapib and ezetimibe in adults with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD), who have not achieved adequate LDL cholesterol control with existing lipid-lowering therapies.

The announcement was made by Michael Davidson, M.D., CEO of NewAmsterdam Pharma, who emphasized the significance of this milestone in advancing obicetrapib. Davidson noted positive trends in physician and patient interest across four ongoing Phase 3 studies: BROOKLYN, BROADWAY, PREVAIL, and TANDEM. These trials are part of the company's efforts to offer a simple, once-daily tablet to millions suffering from dyslipidemia.

The Phase 3 TANDEM trial, which is double-blind and placebo-controlled, enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL. The trial's primary goal is to assess the effect of a 10 mg dose of obicetrapib combined with 10 mg of ezetimibe on LDL-C levels, compared to individual therapies and a placebo. Secondary objectives include evaluating the impacts on lipoprotein(a), apolipoprotein B, and non-HDL cholesterol, along with the safety and tolerability of the combination.

Dr. Ashish Sarraju from the Cleveland Clinic highlighted the global health impact of cardiovascular disease and the limitations of current therapies like statins and ezetimibe. He expressed optimism about obicetrapib's potential role in LDL-C lowering and cardiovascular disease treatment, particularly when combined with ezetimibe.

Obicetrapib is a low-dose CETP inhibitor developed by NewAmsterdam Pharma to address the shortcomings of current LDL-lowering treatments. Previous Phase 2 trials, including ROSE2, TULIP, ROSE, and OCEAN, have shown significant LDL-lowering effects with a safety profile comparable to placebo. The company is also conducting the BROADWAY and BROOKLYN Phase 3 trials to evaluate obicetrapib as a monotherapy in addition to maximally tolerated lipid-lowering therapies. The TANDEM trial focuses on the fixed-dose combination of obicetrapib and ezetimibe.

Patient enrollment for the BROADWAY trial began in January 2022, for BROOKLYN in July 2022, and for TANDEM in March 2024, with completions in April 2023, July 2023, and July 2024, respectively. Additionally, the PREVAIL Phase 3 cardiovascular outcomes trial, which started in March 2022, aims to evaluate obicetrapib's potential to reduce major adverse cardiovascular events, including death, heart attacks, strokes, and non-elective coronary revascularizations. NewAmsterdam completed the PREVAIL trial enrollment in April 2024, randomizing over 9,500 patients.

NewAmsterdam Pharma is dedicated to enhancing patient care for those with metabolic diseases not adequately managed by current therapies. The company aims to provide safe, effective, and convenient LDL-lowering treatments. Their numerous Phase 3 studies are investigating obicetrapib, both as a standalone and in combination with ezetimibe, as additional therapies to statins for patients with elevated LDL-C at risk for cardiovascular disease.