NewAmsterdam Pharma announced a win in the first of its four Phase III, pivotal trials, showing its lead cardio candidate obicetrapib can reduce cholesterol levels.
The BROOKLYN trial (NCT05425745) is the first of four studies in NewAmsterdam’s portfolio and is designed to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
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The study met its primary endpoint, achieving an LS mean reduction of low-density lipoprotein cholesterol (LDL-C) of 36.3% compared to placebo at week 12, with an increase in response to 41.5% at one year.
Other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB), also met statistical significance.
NewAmsterdam’s chief scientific officer Dr John Kastelein said: “My career has been dedicated to the treatment of patients with familial hypercholesterolemia. Many of these patients have exhausted available treatment options. Our goal is to provide physicians and patients with a novel, once-daily, low dose, oral option that can potentially transform the treatment landscape.”
The drug remained well-tolerated, with safety results comparable to placebo and no increase in blood pressure, with a lower discontinuation rate for patients on obicetrapib (7.6%) versus placebo (14.4%).
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By GlobalDataThe 52-week trial enrolled 354 patients who were randomised on a 2:1 ratio of obicetrapib to placebo.
Obicetrapib is a novel, oral, low-dose cholesterylester transfer protein (CETP) inhibitor. If approved, it would be the first CETP inhibitor to advance to clinical practice.
NewAmsterdam’s Chief executive officer Michael Davidson said: “Despite the widespread availability of lipid-lowering therapies, CVD-related deaths have risen, and patients remain above LDL-C targets. Patients and their doctors need additional options.”
Full data from the BROOKLYN trial will be presented at an upcoming medical conference.
Other studies in the pipeline investigating obicetrapib are BROADWAY, PREVAIL and TANDEM which are due to readout over the next 12 months.
BROADWAY (NCT05425745) is investigating the drug in patients with HeFH and/or atherosclerotic cardiovascular disease, (ASCVD) who are not adequately controlled by lipid-modifying therapies.
PREVAIL (NCT05202509) is investigating the candidate in patients with ASCVD which is not controlled despite maximally tolerated lipid-modifying therapies.
Finally, TANDEM (NCT06005597) is evaluating the drug in combination with maximally tolerated lipid-modifying therapy (ezetimibe) in patients with HeFH and/or ASCVD.
The drug has also been investigated in Alzheimer’s disease.
