NewAmsterdam Pharma Co. N.V. (NAMS) announced on Wednesday the promising results from the Phase 3 TANDEM clinical trial. This study assessed the efficacy of a fixed-dose combination treatment comprising 10 mg of Obicetrapib and 10 mg of Ezetimibe.
The trial included adult participants afflicted with heterozygous familial hypercholesterolemia and/or atherosclerotic cardiovascular disease, or those presenting with multiple ASCVD risk factors. These individuals had not achieved adequate LDL-C control, despite utilizing the highest tolerated lipid-lowering therapies.
The trial successfully met all co-primary endpoints, with the Obicetrapib and Ezetimibe combination demonstrating a least squares (LS) mean reduction of 48.6% in LDL-C levels compared to the placebo by day 84.
NewAmsterdam Pharma anticipates that this data will bolster its regulatory submissions across international markets.
Despite these positive results, shares of NewAmsterdam are currently experiencing a decline of 13.26%, trading at $20.15 on the Nasdaq.