NewAmsterdam Pharma Company N.V. announced statistically significant and clinically meaningful topline results from the Phase 2b dose-finding trial of obicetrapib, the company's oral, low-dose and once-daily cholesteryl ester transfer protein (“CETP”) inhibitor, as an adjunct to stable statin therapy in Japanese patients with dyslipidemia. Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan. The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients.

The trial enrolled 102 adult participants, who were randomized 1:1:1:1 to receive obicetrapib 2.5mg, 5mg, 10mg or placebo for a 56-day treatment period. Patients treated with obicetrapib 2.5mg, 5mg, or 10mg, achieved a median reduction in LDL-C of 24.8%, 31.9%, and 45.8%, respectively, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 0.9%. In addition, patients treated with obicetrapib 10mg achieved a median reduction in apolipoprotein B (“Apo B”) of 29.7%, compared to a 1.2% reduction in patients treated with placebo, and a median reduction in non-high-density lipoprotein cholesterol (“non-HDL-C”) of 37.0%, as compared to a 0.4% reduction in patients treated with placebo.

The p-value for each endpoint compared to placebo was <0.0001. Overall, the different dosages of obicetrapib were observed to be well-tolerated, with a safety profile comparable to placebo.