NewAmsterdam Pharma (NewAmsterdam), a clinical-stage company focused on the research and development of transformative oral therapies for metabolic diseases, announced new clinical data from post-hoc analyses of its Phase 2b Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (ROSE) clinical trial, showing that patients treated with obicetrapib were more likely to achieve low-density lipoprotein cholesterol (LDL-c) target guideline goals compared to patients treated with placebo.

These data were presented in late-breaking oral presentations at the 90th European Atherosclerosis Society (EAS) Congress, May 22-25, 2022 in Milan, Italy and the 2022 National Lipid Association (NLA) Scientific Sessions, June 2-5, 2022 in Scottsdale, Arizona.

Evidence from observational studies conducted in the United States and Europe suggest that between 75% and 80% of very high-risk primary and secondary prevention patients fail to achieve their target guideline goals.1,2 In the new data presented at EAS and NLA, NewAmsterdam showed that 82.5% of patients treated with the 10mg dose of obicetrapib and high-intensity statin (HIS) therapy achieved the LDL-c target of <70 mg/dL, compared to 20% of patients treated with placebo, and 60% achieved the LDL-c target of <55 mg/dL, compared to 5% of patients treated with placebo. In previously reported data from the ROSE study, treatment with the 10mg dose of obicetrapib on top of HIS therapy reduced mean LDL-c levels by 51% from baseline.

“We are delighted to present post-hoc analyses from the ROSE clinical trial, which further support the potential of obicetrapib to solve a substantial unmet need in dyslipidemia,” said John Kastelein, M.D., Ph.D., FESC, chief scientific officer of NewAmsterdam Pharma. “Despite the widespread recognition that elevated levels of LDL-c are causal in cardiovascular disease, too many very high-risk primary and secondary prevention patients fail to achieve their target goals and remain at unacceptably high risk. Together, with the full data we presented last year, these new results suggest that obicetrapib has the potential to address the two primary goals of lipid-lowering therapy, offering patients a substantial reduction in absolute LDL-c levels and a greater chance of achieving recommended LDL-c targets, which is the key modifiable risk factor for reducing their chance of experiencing a major adverse cardiac event.”