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

-- TANDEM is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (“FDC”) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with HeFH, ASCVD or ASCVD risk equivalents requiring additional lowering of low-density lipoprotein cholesterol (“LDL-C”) --

-- Company expects to report topline data in the first quarter of 2025 --

-- TANDEM is being conducted in parallel with BROOKLYN, BROADWAY and PREVAIL pivotal Phase 3 studies; data from BROOKLYN and BROADWAY expected in 3Q and 4Q 2024, respectively --

NAARDEN, The Netherlands and MIAMI, March 12, 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 dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC 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.

“Ezetimibe has become an established therapy for patients with elevated cholesterol at high risk of CVD; however, a significant proportion of these patients remain unable to achieve target LDL-C levels, highlighting a major unmet need. The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk. By combining obicetrapib, if approved, with ezetimibe in a once-daily pill, this FDC therapy could meaningfully improve the tools available to physicians for addressing elevated LDL-C, and lead to improved health outcomes for millions of people living with increased risk for CVD globally,” said Ashish Sarraju, M.D., Cardiovascular Medicine, Cleveland Clinic.

The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo. Secondary objectives include evaluating the effect of the FDC on apolipoprotein B (“ApoB”) and non-high-density lipoprotein cholesterol (“non-HDL-C”). The trial will also evaluate the safety and tolerability profile of the FDC.