NAARDEN, Netherlands--(BUSINESS WIRE)--NewAmsterdam Pharma (NAP), a clinical-stage company focused on the research and development of transformative therapies for cardiometabolic diseases, today announced dose administration for the first patient in ROSE2, the Company’s Phase 2 trial of obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor. ROSE2 is a placebo-controlled, double-blind, randomized, Phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg in combination with ezetimibe 10 mg and as monotherapy, in each case as an adjunct to high-intensity statin therapy. Ezetimibe is a cholesterol absorption inhibitor that works by partially blocking the absorption of cholesterol in the small intestine, causing the upregulation of low-density lipoprotein (LDL) receptors - a mechanism of action that NewAmsterdam believes could be additive and potentially synergistic with CETP inhibition for reducing levels of low-density lipoprotein cholesterol (LDL-c).
“Building off the positive data from our Phase 2 ROSE study presented at the American Heart Association’s (AHA) Scientific Sessions in November 2021, we are excited about ROSE2’s potential to show the effectiveness of combining obicetrapib with ezetimibe in reducing LDL-c. NewAmsterdam is developing a fixed-dose combination of these two drugs as a single, once-daily, low-dose oral pill, which we hope will become an exceptionally potent option for patients needing further LDL-C reduction,” said Dr. Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma. “There is still a substantial unmet need for simple, well-tolerated, oral, low-dose therapy options for patients at high risk for cardiovascular disease who are unable to meet their current lipid management goals. We look forward to advancing our development program with the addition of the ROSE2 study alongside our two Phase 3 programs, BROADWAY and PREVAIL, to help find a solution for this unmet need.”
Participants will be randomized to receive combination therapy (i.e., obicetrapib 10 mg + ezetimibe 10 mg), obicetrapib monotherapy (obicetrapib 10 mg), or placebo. The primary objective of the ROSE2 trial is to evaluate the efficacy endpoint, which is the percent change from Day 1 to Day 84 in LDL-c for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group.
A total of 108 patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10mg obicetrapib + 10mg ezetimibe combination therapy, dosed as a once-daily oral treatment for an 84-day treatment period.
About Obicetrapib
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.
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.
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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 |
