Positive top-line data for NewAmsterdam’s obicetrapib and ezetimibe combo

Dutch clinical-stage biotech NewAmsterdam Pharma (Nasdaq: NAMS), which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial.

The company said that the TANDEM study will support global regulatory filings for the 10mg obicetrapib and 10mg ezetimibe fixed-dose combination in adult patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors, whose low-density lipoprotein cholesterol (LDL-C) is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.

William Blair analyst Matt Phipps says the results generally line up with investors' expectations. But they fell short of a mid-stage study called Rose2 where the two drugs led to an average 59% reduction in LDL cholesterol. According to a recent survey, most investors expected NewAmsterdam's fixed-dose combination (FDC) to lead to a 50% to 54% reduction in LDL cholesterol, Mr Phipps said in his report.