NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a biopharmaceutical company in the late stages of clinical development, has announced the presentation of new data on its drug candidate
obicetrapib at two major scientific conferences. Obicetrapib, a
CETP inhibitor, is being developed as an oral, low-dose treatment for patients with
hypercholesterolemia and
cardiovascular disease who do not respond well to existing therapies.
The first presentation will occur at the European Atherosclerosis Society (EAS) 92nd Congress in Lyon, France, from May 26-29, 2024. Researchers will present data from several clinical trials, including the OCEAN and ROSE2 studies, which demonstrate obicetrapib’s ability to increase pre-beta1 HDL and lipophilic antioxidants. Other data will show significant reductions in
lipoprotein(a) when obicetrapib is used alongside high-intensity statins, and the enhancement of
LDL receptor-mediated VLDL clearance and increased net fecal sterol excretion when combined with
ezetimibe. These findings suggest potential benefits in lipid and lipoprotein biomarkers for patients undergoing treatment.
At the National Lipid Association (NLA) 2024 Scientific Sessions in Las Vegas, Nevada, from May 30 to June 2, 2024, obicetrapib will also be showcased. Key highlights include further evidence of its efficacy in reducing lipoprotein(a) levels when added to high-intensity statins and its synergistic effects with ezetimibe on circulating LDL particles.
Obicetrapib's development has shown promising results across several Phase 2 trials, including ROSE2,
TULIP, ROSE, and OCEAN. These trials evaluated the drug both as a monotherapy and in combination with other treatments, demonstrating significant LDL-C lowering effects with a safety profile comparable to placebo. The company is currently conducting two pivotal Phase 3 trials, BROADWAY and BROOKLYN, to test obicetrapib as an adjunct to maximally tolerated lipid-lowering therapies in patients with cardiovascular disease (CVD). Additionally, the TANDEM trial is assessing a fixed-dose combination of obicetrapib and ezetimibe.
The Phase 3 PREVAIL cardiovascular outcomes trial, which began in March 2022, aims to evaluate obicetrapib's potential to reduce major adverse cardiovascular events, including cardiovascular death,
non-fatal myocardial infarction,
non-fatal stroke, and non-elective coronary revascularization. This trial has enrolled over 9,500 patients and completed enrollment in April 2024.
NewAmsterdam Pharma’s mission is to address significant unmet needs in
metabolic diseases by developing safe, well-tolerated, and easy-to-use LDL-lowering therapies. Their focus on obicetrapib aims to provide a treatment option for patients who cannot adequately manage their condition with current medications. The company's research efforts are driven by the goal of improving patient care and outcomes for those at risk of or suffering from cardiovascular diseases.
Overall, the new data presentations at the EAS Congress and NLA Scientific Sessions underscore the potential of obicetrapib as an innovative therapy for managing elevated LDL-C levels in patients with cardiovascular risk, highlighting its possible role in future treatment paradigms.
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