New Amsterdam Pharma Completes Phase III Trial for Combination Therapy

New Amsterdam Pharma Completes Phase III Trial for Combination Therapy

Alina Petrovsky
2 min read

NewAmsterdam Pharma Advances Phase III TANDEM Trial for HeFH and ASCVD

Dutch biotech firm NewAmsterdam Pharma has achieved a significant milestone by successfully enrolling 407 patients in the Phase III TANDEM trial. This trial focuses on a combination therapy for treating heterozygous familial hypercholesterolaemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD). It involves a fixed-dose combination of obicetrapib and ezetimibe, aiming to address uncontrolled LDL-C levels and other lipid parameters in adults with these conditions. The primary objective is to evaluate the impact of this combination compared to monotherapies and a placebo, with the anticipation of releasing topline data in the first quarter of 2025. NewAmsterdam Pharma is dedicated to advancing treatments for metabolic diseases where current therapies are insufficient or poorly tolerated and has also shown promising results in early Alzheimer's disease treatment.

Key Takeaways

  • NewAmsterdam Pharma completes enrollment in Phase III TANDEM trial for HeFH and ASCVD.
  • A fixed-dose combination of obicetrapib and ezetimibe is being evaluated in the trial.
  • The primary goal is to assess LDL-C reduction compared to monotherapies and placebo.
  • The trial also aims to evaluate effects on other lipid parameters and safety monitoring.


The success of NewAmsterdam Pharma's Phase III TANDEM trial could have a transformative impact on the treatment of HeFH and ASCVD, potentially affecting both patients and competitors such as Amgen and Pfizer. This success could also bolster NewAmsterdam's stock and R&D funding. Conversely, failure could impede future trials. The focus on LDL-C reduction and additional lipid parameters in the trial aims to address unmet medical needs, potentially leading to safer and more effective therapies. In the long term, improved outcomes could result in reduced healthcare costs and improved patient quality of life.

Did You Know?

  • Heterozygous Familial Hypercholesterolemia (HeFH):
    • A genetic disorder characterized by high levels of low-density lipoprotein cholesterol (LDL-C) from birth.
    • Individuals with HeFH have a mutation in one of the genes responsible for LDL receptor function, leading to impaired clearance of LDL-C from the blood.
    • This condition significantly increases the risk of early cardiovascular disease.
  • Atherosclerotic Cardiovascular Disease (ASCVD):
    • A condition characterized by the buildup of cholesterol and other substances in and on the artery walls, leading to the formation of plaques.
    • ASCVD includes a range of conditions such as coronary artery disease, carotid artery disease, and peripheral artery disease.
    • It is a major cause of heart attacks, strokes, and limb amputations.
  • Obicetrapib and Ezetimibe Combination Therapy:
    • Obicetrapib: A cholesterol ester transfer protein (CETP) inhibitor that increases HDL-C (good cholesterol) and reduces LDL-C levels.
    • Ezetimibe: A drug that inhibits the absorption of cholesterol by the small intestine, reducing LDL-C levels.
    • Combining these two drugs aims to provide a synergistic effect in lowering LDL-C and improving lipid profiles in patients with HeFH and ASCVD.

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