NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD - Seite 2

NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl. Patients will be randomized to one of the following groups: placebo, 10 mg obicetrapib, 10mg ezetimibe, or obicetrapib 10mg and ezetimibe 10mg FDC tablet, all groups dosed as a once-daily oral treatment for an 84-day treatment period. HeFH is an inherited genetic disorder that causes dangerously high cholesterol levels. Patients with ASCVD have established cardiovascular diseases characterized by the buildup of plaque in the arteries, including coronary artery stenosis, myocardial infarction or stroke. Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

“The initiation of the Phase 3 TANDEM trial represents a significant milestone for NewAmsterdam, as we are now progressing four pivotal Phase 3 trials – BROADWAY, BROOKLYN, PREVAIL, and TANDEM,” said Michael Davidson, M.D., Chief Executive Officer at NewAmsterdam Pharma. “Supported by compelling data from our Phase 2 ROSE2 trial, which demonstrated meaningful reductions in LDL-C, non-HDL, and ApoB in patients already using high-intensity statin therapy, we believe the combination of obicetrapib, if approved, and ezetimibe, in a simple and convenient once-daily tablet, is highly synergistic, with the potential to significantly improve cardiovascular disease treatment for millions of people living with dyslipidemia. TANDEM is a critical component of NewAmsterdam’s multi-pronged clinical strategy, and we are optimistic that favorable results from this trial, together with our other ongoing Phase 3 studies, can position us to advance our novel CETP inhibitor franchise as a much-needed therapeutic solution.”

About Obicetrapib

Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company’s Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company’s Phase 2 ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo, including no increase in blood pressure or muscle related side effects. Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels (“dyslipidemia”) in NewAmsterdam’s clinical trials to date. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients. The Company began enrolling patients in BROADWAY in January 2022 and in BROOKLYN in July 2022 and completed enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.