NewAmsterdam Pharma Reports Positive Phase 3 TANDEM Trial Results for Obicetrapib and Ezetimibe Combination

NewAmsterdam Pharma Company N.V., a clinical biopharmaceutical firm developing treatments for cardiovascular disease, announced promising results from its Phase 3 TANDEM clinical trial. This study assessed the efficacy of a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe in reducing low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD), whose LDL-C levels remained high despite maximally tolerated lipid-lowering therapy.

The trial's co-primary endpoints focused on the percent change from baseline in LDL-C levels at day 84 for the combination therapy compared to individual monotherapies and placebo. Secondary endpoints included changes in other biomarkers such as lipoprotein(a), non-high-density lipoprotein cholesterol, and apolipoprotein B. The results showed that the obicetrapib-ezetimibe combination achieved a significant mean reduction of 48.6% in LDL-C compared to placebo.

The trial enrolled 407 patients who were randomized into four groups: one receiving the fixed-dose combination, one receiving obicetrapib alone, one receiving ezetimibe alone, and a placebo group. At baseline, the average LDL-C level in the combination therapy group was 97 mg/dL, despite high-intensity statin use by around 74% of participants.

The combination therapy was well tolerated, with safety results similar to those seen in previous studies. Dr. John Kastelein, Chief Scientific Officer of NewAmsterdam, noted the significance of these findings, emphasizing the potential of the new treatment to help patients achieve LDL-C targets and enhance cardiovascular outcomes. Dr. Michael Davidson, Chief Executive Officer of NewAmsterdam, echoed these sentiments, highlighting the potential global regulatory support the results provide.

The study revealed that the fixed-dose combination lowered LDL-C by approximately 50% at day 84, with over 70% of patients achieving LDL-C levels below 55 mg/dL. This outcome is significant for patients who do not respond adequately to existing therapies, offering a new, effective treatment option in the form of a once-daily oral tablet.

NewAmsterdam plans to present additional TANDEM trial results at future medical conferences and publish the findings in medical journals. This trial is part of NewAmsterdam's broader Phase 3 clinical development program, which includes other studies such as BROOKLYN, BROADWAY, and PREVAIL, all aimed at evaluating obicetrapib's efficacy in various patient populations.

Obicetrapib is a low-dose CETP inhibitor designed to provide additional LDL-C lowering for patients inadequately served by current treatments. The drug has shown promise in multiple Phase 2 and Phase 3 trials, demonstrating significant LDL-C reductions and a safety profile comparable to placebo. NewAmsterdam is working with the Menarini Group for the commercialization of obicetrapib in Europe.

NewAmsterdam Pharma is committed to improving patient care in populations with metabolic diseases where current therapies fall short. The company is focused on developing safe, well-tolerated, and convenient LDL-lowering treatments to address the needs of patients at risk of cardiovascular disease.