NewAmsterdam Pharma Announces 2024 Strategic Priorities

-- Positioned for three Phase 3 trial readouts over the next 18 months --

-- Topline data expected from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and BROADWAY trial in ASCVD in 4Q 2024 --

-- Plan to initiate TANDEM, a pivotal Phase 3 trial evaluating obicetrapib and ezetimibe fixed-dose combination, in 1Q 2024; topline data expected in 1Q 2025 --

-- On-track to complete enrollment in Phase 3 PREVAIL CVOT in 1Q 2024; topline data expected in 2026 --

-- Well-capitalized with cash to support operations through BROADWAY, BROOKLYN, and PREVAIL readouts --

NAARDEN, the Netherlands and MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on its clinical development programs and outlined its strategic priorities for 2024.

“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.”

Dr. Davidson continued, “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.”