NewAmsterdam Pharma announces upcoming milestones

“NewAmsterdam is entering 2024 on the precipice of a major transformation, with the potential to deliver significant benefit to patients globally and create value for our shareholders,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “In the year ahead, we are on track to report topline results from our first two pivotal Phase 3 trials of obicetrapib, BROOKLYN and BROADWAY. We are optimistic that these data will build on our prior Phase 2 trials, where we observed a robust impact on lipid and lipoprotein parameters believed to be predictive of CVD risk. We continue to believe that our oral small molecule, low-dose, once-daily CETP inhibitor, if approved, has the potential to become the preferred LDL-C lowering therapy for the millions of dyslipidemia patients who are underserved by existing therapies. In addition, in the first quarter, we expect to complete enrollment in PREVAIL, our cardiovascular outcomes trial, and initiate a fourth pivotal Phase 3 trial evaluating a fixed-dose combination of obicetrapib and ezetimibe, which was observed in our Phase 2 trial to reduce LDL-C by 63%. Taken together, we believe our comprehensive Phase 3 program will showcase obicetrapib’s potential to help many more patients reach guideline-mandated LDL-C goals and, as a result, reduce suffering from major adverse cardiac events, while also providing physicians with multiple treatment options to optimize the care of each patient. We look forward to advancing our clinical program, while investing in our commercial organization and laying the groundwork for a successful global launch if obicetrapib receives the necessary marketing approvals.” Program Updates and Upcoming Milestones: NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily cholesteryl ester transfer protein inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk CVD patients. In 2023, NewAmsterdam reported positive, statistically significant and clinically meaningful data from two Phase 2 clinical trials of obicetrapib: the Phase 2 ROSE2 trial, which evaluated obicetrapib in combination with ezetimibe, and a Phase 2b dose-finding trial, which evaluated obicetrapib in Japanese patients. In total, the Company has completed six Phase 1 or 2 clinical trials and tested obicetrapib in over 800 patients. Statistically significant LDL-lowering was observed in each of the Company’s completed Phase 2 clinical trials, combined with generally moderate side effects and no drug-related, treatment-emergent serious adverse events. The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, BROADWAY and PREVAIL. In addition, the Company plans to initiate a fourth Phase 3 trial, TANDEM, evaluating a fixed-dose combination of obicetrapib and ezetimibe. BROOKLYN is evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primary objective is to evaluate the effect of obicetrapib on LDL-C levels. Secondary objectives include evaluating the effect of obicetrapib on non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein. The trial is also evaluating the safety and tolerability profile of obicetrapib. NewAmsterdam completed enrollment of approximately 350 patients in April 2023 and expects to report topline data in the third quarter of 2024. BROADWAY is evaluating obicetrapib in adult patients with HeFH and/or established atherosclerotic cardiovascular disease, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primary objective is to evaluate the effect of obicetrapib on LDL-C levels at day 84. Secondary objectives include evaluating the effect of obicetrapib on ApoB, Lp, HDL-C, and non-HDL-C, at day 84, and on LDL-C levels at days 180 and 365. The trial is also evaluating the safety and tolerability of obicetrapib. NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024. PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primarily objective is to evaluate the effect of obicetrapib on the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infraction, non-fatal stroke, or non-elective coronary revascularization. Secondary objectives include evaluating the effect of obicetrapib on all-cause mortality, total cardiovascular events, new-onset diabetes mellitus, and change in LDL-C, non-HDL-C, and ApoB levels. NewAmsterdam expects to complete patient enrollment in PREVAIL in the first quarter of 2024 and to report topline data in 2026. TANDEM is designed as a pivotal Phase 3 clinical trial to evaluate obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy. The Company expects to initiate TANDEM in the first quarter of 2024 and to report topline data in the first quarter of 2025. Also in 2023, NewAmsterdam reported positive initial data from a Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease who carry at least one copy of the apolipoprotein E4 mutation. NewAmsterdam anticipates sharing the full results from this Phase 2a clinical trial in a forthcoming publication or in a presentation at a medical meeting.