NewAmsterdam Phase III obicetrapib trial meets endpoint, but disappoints

Dutch drug developer NewAmsterdam Pharma (Nasdaq: NAMS) today announced what it called positive top-line data from the company’s Phase III BROOKLYN clinical trial (NCT05425745).

BROOKLYN, the first of four studies in NewAmsterdam’s pivotal clinical development program, was designed to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia (HeFH), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.

The company noted that the BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36.3% (p < 0.0001) compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5% (p < 0.0001). The observed reductions in other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB), met statistical significance and were consistent with data reported from the Company’s prior clinical trials.