Initiation of TANDEM Trial: NewAmsterdam's Phase 3 Study on Obicetrapib-Ezetimibe Combo for HeFH/ASCVD Patients

NewAmsterdam Pharma, a clinical-stage biopharmaceutical firm, has initiated a Phase 3 clinical trial named TANDEM. This trial aims to assess a fixed-dose combination of obicetrapib and ezetimibe as a supplementary treatment to diet and existing lipid-lowering therapies for patients with HeFH, ASCVD, or equivalent risk factors whose LDL-C levels are not sufficiently reduced. The primary goal of the TANDEM study is to determine the impact of the combined 10mg dose of obicetrapib and ezetimibe on LDL-C levels, when compared to individual treatments of the same doses and a placebo. It will also examine the effects on apolipoprotein B and non-high-density lipoprotein cholesterol, as well as the safety and tolerability of the combination.

The trial plans to enroll around 400 patients who are already on the maximum tolerated lipid-modifying therapies and have a baseline LDL-C level of at least 70 mg/dL. The patients will be randomly assigned to receive daily oral treatments for 84 days, which include placebo, 10 mg obicetrapib, 10 mg ezetimibe, or the combined FDC tablet. HeFH is a genetic disorder leading to very high cholesterol levels, while ASCVD patients have existing cardiovascular diseases with arterial plaque buildup.

Obicetrapib, being developed by NewAmsterdam, is a novel CETP inhibitor intended to address the limitations of current LDL-lowering treatments. The company believes that if approved, obicetrapib could serve as a daily oral CETP inhibitor to reduce LDL-C. Previous trials have shown significant LDL-C reduction with a tolerability profile similar to placebo, without increasing blood pressure or muscle-related side effects. Over 800 patients with dyslipidemia have been treated with obicetrapib in NewAmsterdam's trials, demonstrating its strong tolerability.

NewAmsterdam Pharma is dedicated to improving patient care for those with metabolic diseases where current therapies are inadequate or poorly tolerated. The company is conducting multiple Phase 3 studies to evaluate obicetrapib as a monotherapy or in combination with ezetimibe for LDL-C lowering in patients at risk of CVD with high LDL-C levels. The TANDEM trial is a significant step in the company's clinical strategy, and favorable results could position NewAmsterdam to offer a much-needed therapeutic solution for cardiovascular disease treatment.