Exhibit 99.1
NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROADWAY Clinical Trial Evaluating
Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia and/or Established Atherosclerotic
Cardiovascular Disease
— Exceeded Target Enrollment; Expect to Randomize More Than 2,500 Patients —
— Topline Results Expected in 2H 2024 –
Naarden, the Netherlands and Miami, USA; July 25, 2023 – 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” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or established atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally. NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.
“We are pleased to announce the over enrollment in the Phase 3 BROADWAY trial, highlighting the robust demand for a convenient oral therapy and marking an important next step toward our goal of delivering obicetrapib to the millions of patients who, despite being treated with maximally tolerated lipid-lowering therapy, still do not reach their risk-based LDL-C goals,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Emerging clinical data continue to demonstrate the potential for our CETP inhibitor to solve a substantial unmet need in dyslipidemia by reducing LDL-C and impacting a number of other lipid and lipoprotein parameters predictive of cardiovascular disease risk.”
The double-blind, placebo-controlled Phase 3 BROADWAY trial is expected to randomize over 2,500 patients with HeFH and/or ASCVD across eight countries including the United States, Netherlands, Japan and China. The mean baseline LDL-C for enrolled patients is approximately 100 mg/dL despite high intensity statin use reported by greater than 60% of patients during screening. Females comprise approximately 30% of the study population and the median age of participants is approximately 66 years. Patients were randomized to receive placebo or 10 mg obicetrapib, on top of maximally tolerated lipid-lowering therapy, dosed as a once-daily oral treatment with or without food for 52 weeks. 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 apolipoprotein B, lipoprotein(a), high density lipoprotein cholesterol (“HDL-C”), non-HDL-C, total cholesterol and triglycerides at day 84, and on LDL-C levels at days 180 and 365. The trial is also evaluating the safety and tolerability of obicetrapib.
“HeFH and ASCVD can be devastating diseases which, if inadequately addressed, can result in myocardial infarction, cerebral infarction, or cardiovascular death,” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “It has become increasingly clear that lower levels of LDL-C are directly correlated with a reduced risk for major adverse cardiovascular events. With obicetrapib, we aim to deliver LDL-C reductions that are substantially better than currently available non-statin oral therapies, in a convenient, tolerable formulation. We are pleased to have both BROADWAY and BROOKLYN, the two pivotal Phase 3 trials necessary to support a potential LDL regulatory filing, fully enrolled and look forward to reporting data from both studies in the second half of 2024.”
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
