NAARDEN, Netherlands & MIAMI–(BUSINESS WIRE)–NewAmsterdam Pharma (NewAmsterdam), a clinical-stage company focused on the research and development of transformative therapies for metabolic diseases, today announced the publication of a new meta-analysis in the European Heart Journal’s publication Cardiovascular Pharmacotherapy, discussing the effect of cholesteryl ester transfer protein (CETP) inhibitors on new-onset diabetes. This research was co-authored by NewAmsterdam’s chief scientific officer, John Kastelein, M.D., Ph.D., Katerina Dangas, University of Oxford, and Dr. Ann Marie Navar, Department of Internal Medicine, University of Texas Southwestern Medical Center.
The analysis examines the effect CETP inhibitors have on reducing new-onset diabetes and related glycemic measures in patients. Trials have shown a consistent reduction in the risk of new-onset diabetes in patients using CETP inhibitor therapy, while use of statins has been shown to increase the risk of new-onset diabetes. In four randomized trials, CETP inhibitors significantly decreased the risk of new-onset diabetes by 16%, with low between-trial heterogeneity. CETP inhibitors also significantly improved or demonstrated a trend towards improvement in glycemic measures in those with and without diabetes.
“The results from this meta-analysis highlight the potential of NewAmsterdam’s CETP inhibitor, obicetrapib,” said Dr. John Kastelein, chief scientific officer of NewAmsterdam. “Obicetrapib, a novel, oral, once-daily, low-dose therapy, has the potential to play an important role in the treatment landscape for the lowering of low-density lipoprotein cholesterol (LDL-c), while increasing high-density lipoprotein cholesterol (HDL-c). The studies reviewed in this analysis demonstrated risk reduction in new-onset diabetes, highlighting another potential benefit of obicetrapib. Given the relationship between cardiovascular disease and diabetes, we are optimistic that obicetrapib can offer a differentiated product profile compared to existing standard of care, improving the overall health of patients on therapy by reducing both their risk of cardiovascular disease and diabetes.”
The publication concludes that future trials of CETP inhibitors and potentially other HDL-raising agents should evaluate new-onset diabetes and reversal of existing type II diabetes as secondary endpoints to further define the effect of this class on reducing new-onset disease. NewAmsterdam is currently evaluating obicetrapib in two Phase 3 trials, BROADWAY and PREVAIL, and a secondary Phase 2 trial, ROSE2; one secondary objective of PREVAIL is to evaluate the effect of obicetrapib on new-onset diabetes mellitus.
Obicetrapib is a selective cholesteryl ester transfer protein (CETP) inhibitor in development for lowering low-density lipoprotein cholesterol (LDL-c) and preventing major adverse cardiovascular events. More than 100 million people globally are not achieving LDL-c goals despite the current available standard of care. Obicetrapib was previously tested in ROSE and TULIP1 randomized double-blind, placebo-controlled Phase 2 trials. Results from the ROSE trial, presented in November 2021 at the AHA Scientific Sessions, demonstrated that patients on statin therapy who received 5 mg of obicetrapib saw an LDL-c reduction of 42%. Patients who were part of the 10 mg cohort experienced a 51% reduction versus baseline, while the placebo cohort experienced a 7% reduction versus baseline. Both doses were well tolerated, with no serious adverse effects in the two cohorts and two serious AEs in the placebo arm. Currently, Obicetrapib is being tested in two Phase 3 trials, BROADWAY and PREVAIL, and a secondary Phase 2 trial, ROSE2. These studies are intended to examine obicetrapib as a combination therapy as well as its efficacy in adjunct to diet and a maximally tolerated lipid-lowering therapy, and reduction of major adverse cardiovascular events.
About NewAmsterdam Pharma
NewAmsterdam Pharma is a private clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where traditional therapies have been unsuccessful or are not tolerated. NewAmsterdam is investigating obicetrapib, a next-generation cholesteryl ester transfer protein (CETP) inhibitor, as the preferred LDL-c-lowering therapy for high-risk cardiovascular disease (CVD) patients. The Company’s ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) showed that obicetrapib 10mg reduced LDL-c by 51% versus baseline in patients on statin therapy (vs. a 7% reduction in the placebo arm). Based in the Netherlands, NewAmsterdam was founded in 2019 by the venture capital firm Forbion and John Kastelein, and closed a $196M (€161M) Series A financing in January 2021 led by Forbion, Morningside Ventures and Ascendant BioCapital. For more information, please visit: www.newamsterdampharma.com.
1 Hovingh, G. K., Kastelein, J. J. P., van Deventer, S. J. H., Round, P., Ford, J., Saleheen, D., Rader, D. J., Brewer, H. B., & Barter, P. J. (2015). Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. In The Lancet (Vol. 386, Issue 9992, pp. 452–460). Elsevier BV. https://doi.org/10.1016/s0140-6736(15)60158-1