New Amsterdam Pharma has announced positive topline results from its Phase III TANDEM trial, evaluating the efficacy of its fixed-dose combination of obicetrapib and ezetimibe in reducing cholesterol levels. The trial focused on patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) who are already on maximally tolerated lipid-lowering therapy but still require further LDL-C reduction.
The TANDEM trial (NCT06005597) was a randomized, double-blind, placebo-controlled, multi-center study involving 407 patients across the United States. The study compared the fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe against monotherapy. The co-primary endpoints were the change from baseline in LDL-C levels after 84 days compared to monotherapy and obicetrapib 10 mg compared to placebo after the same period.
The results indicated that the fixed-dose combination met both co-primary endpoints, achieving a statistically significant LS mean reduction of 48.6% in LDL-C levels. Furthermore, the combination was observed to be well-tolerated, with a safety profile comparable to placebo.
Clinical Significance
Elevated LDL-C levels are a major risk factor for cardiovascular diseases, including ASCVD and HeFH. Despite the availability of statins and other lipid-lowering therapies, many patients fail to achieve optimal LDL-C levels, highlighting the need for new treatment options. The TANDEM trial results suggest that the obicetrapib-ezetimibe combination could provide a more effective approach for these patients.
Expert Commentary
Michael Davidson, CEO of New Amsterdam, stated, "We expect these promising results will support our regulatory filings globally and they reinforce our belief that, if approved, obicetrapib in combination with ezetimibe will potentially offer a simple, once-daily treatment capable of significantly reducing LDL-C and improving cardiovascular outcomes."
Ongoing Research
New Amsterdam is also awaiting results from its BROADWAY and PREVAIL trials, further solidifying its commitment to developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C. These trials, along with the BROOKLYN trial, aim to provide a comprehensive dataset supporting the efficacy and safety of obicetrapib as both a monotherapy and in combination with ezetimibe.
