NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors

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[{"type":"text","content":"-- Company expects to report topline data in the first quarter of 2025 --\nNAARDEN, The Netherlands and MIAMI, July 08, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 TANDEM clinical trial evaluating the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies. “Completing enrollment of the pivotal Phase 3 TANDEM trial marks an important step in our mission of advancing obicetrapib through late-stage clinical development and brings us closer to delivering a simple and convenient once-daily tablet to the millions of people suffering from dyslipidemia,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “With positive enrollment trends observed in four ongoing contemporaneous pivotal Phase 3 studies – BROOKLYN, BROADWAY, PREVAIL and TANDEM – we continue to be encouraged by physician and patient interest in our clinical trials, which we believe reflects growing awareness of our CETP inhibitor and its potential ability to address elevated LDL-C and improve health outcomes for millions of patients globally, if approved. We look forward to sharing topline data from the TANDEM study in the first quarter of 2025.” The double-blind, placebo-controlled Phase 3 TANDEM clinical trial enrolled 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who have a baseline LDL-C of at least 70 mg/dL. The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10 mg obicetrapib and 10 mg ezetimibe FDC on the change in LDL-C levels from baseline, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. Secondary objectives include evaluating the...

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