New post-hoc data accepted as late breaking abstracts at the 90th European Atherosclerosis Society (EAS) Congress and 2022 National Lipid Association (NLA) Scientific Sessions
NAARDEN, Netherlands & MIAMI–(BUSINESS WIRE)–NewAmsterdam Pharma (NewAmsterdam), a clinical-stage company focused on the research and development of transformative oral therapies for metabolic diseases, today announced that it will present new post-hoc analyses and additional LDL goal attainment data from its Phase 2b Randomized Study of Obicetrapib as an Adjunct to High Intensity Statin Therapy (ROSE) clinical trial in late-breaking oral presentations at the 90th European Atherosclerosis Society Congress, taking place May 22-25, 2022 in Milan, Italy and the 2022 National Lipid Association (NLA) Scientific Sessions, taking place June 2-5, 2022 in Scottsdale, Arizona. Obicetrapib is NewAmsterdam’s next-generation oral, low-dose and once-daily cholesteryl ester transfer protein (CETP) inhibitor, initially in development for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, both as a monotherapy and in a fixed-dose combination with ezetimibe.
Details of the presentations are as follows:
Presentation at the 90th European Atherosclerosis Society (EAS) Congress:
Presentation Title: Obicetrapib Lowers LDL-C in Patients on High Intensity Statins: Results from the Rose Trial (NCT04753606)
Session Title: 0380 – Late breaker session 1
Session Date/Time: Monday, May 23, 2022, 3:45 – 5:15 p.m. CEST (9:45 – 11:15 a.m. ET)
Presenting Author: Kausik K. Ray, Professor of Public Health, the Director of the Imperial Centre for Cardiovascular Disease Prevention and the Deputy Director of the Imperial Clinical Trial Unit, Imperial College London
Location: Milan, Italy
Presentation at the 2022 National Lipid Association (NLA) Scientific Sessions:
Presentation Title: Obicetrapib Lowers LDL-C in Patients Taking High Intensity Statins – Results from the ROSE Clinical Trial
Session Title: Late Breakers
Session Date/Time: Saturday, June 4, 2022, 12:20 – 12:50 p.m. MT (2:20 – 2:50 p.m. ET)
Presenting Author: Dr. Michael Davidson, CEO of NewAmsterdam Pharma
Location: Scottsdale, Arizona
Topline results from the ROSE study, which met its primary endpoint, were released in July of 2021. ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2b dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. A total of 120 patients were randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. The primary endpoint was met for both doses.
Obicetrapib is a next-generation oral, low-dose and once-daily 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 oral, low-dose and once-daily 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
Spectrum Science on behalf of NewAmsterdam Pharma
Stern Investor Relations on behalf of NewAmsterdam Pharma
P: 1 212-362-1200
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