NewAmsterdam Pharma Announces ROSE Phase 2 Trial Results Accepted for Featured Science Presentation at 2021 AHA Scientific Sessions
As we previously reported, we are enthusiastic about the results of the ROSE trial and the demonstration of greater than 50% LDL-lowering as an adjunct to high intensity statins.
NewAmsterdam Pharma (NAP), a clinical-stage company focused on the research and development of transformative therapies for metabolic diseases, today announced that its Phase 2 Randomized Study of Obicetrapib as an Adjunct to High Intensity Statin Therapy (ROSE) clinical trial has been selected for an oral presentation at the 2021 American Heart Association (AHA) Scientific Sessions on Saturday, November 13, 2021. Obicetrapib is an investigational novel selective cholesteryl ester transfer protein (CETP) inhibitor. NAP is developing obicetrapib for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, in a fixed-dose combination with ezetimibe and as a monotherapy.
Presentation Information
Session Title: Ischemic Heart Disease: New Data on Diagnosis, Prognosis, and Treatment
Presenting Author: Prof. Stephen Nicholls, M.D., Director of MonashHeart, Monash Health and Professor of Cardiology, Monash University, Australia
Session Date/Time: Session FS02, Saturday Nov 13, 2021 4:30 PM - 5:30 PM
Presentation Title: Obicetrapib Lowers LDL-C in Patients Taking High Intensity Statins:
Results From Rose Clinical Trial
Presentation Time: 5:18pm - 5:26pm ET
Presentation Format: Live Zoom presentation
“We are excited to have the opportunity to present the ROSE study results as a featured presentation at this year’s American Heart Association Scientific Sessions,” said Dr. Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma. “AHA provides an ideal forum to present this data in front of top physicians, scientists and researchers in cardiology, as we continue to generate encouraging evidence of obicetrapib’s exceptional LDL-c lowering efficacy for patients with high residual risk for cardiovascular disease who need additional LDL-c lowering beyond that which is currently offered by statins alone. As we previously reported, we are enthusiastic about the results of the ROSE trial and the demonstration of greater than 50% LDL-lowering as an adjunct to high intensity statins. Based on these results, we anticipate initiation of Phase 3 registration trials by the end of this year.”
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 2 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.
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. Over one hundred million people globally cannot achieve LDL-c goals despite current standard of care. Obicetrapib was previously tested in TULIP (published in Lancet), a randomized double-blind, placebo-controlled Phase 2a trial in 364 mildly dyslipidemic patients, which showed that obicetrapib is well-tolerated and effectively lowers LDL-c in patients as a monotherapy and in combination with statins. NAP is working to initiate Phase 3 trials in Q4 2021.
About NewAmsterdam Pharma
Founded in 2019 by the venture capital firm Forbion and John Kastelein, NewAmsterdam Pharma is a privately held, clinical-stage company focused on the research and development of transformative therapies for cardiometabolic diseases. Its mission is to improve patient care in populations. In April 2020, NewAmsterdam acquired Dezima Pharma from Amgen, including all rights for obicetrapib (formerly AMG 899, now TA-8995) a selective cholesteryl ester transfer protein (CETP) inhibitor. In January 2021, NewAmsterdam Pharma closed a $196M (€161M) Series A financing led by Morningside Ventures and Ascendant BioCapital with participation from Forbion, Kaiser Foundation Hospitals, BVF Partners L.P., Population Health Partners, LSP Dementia Fund, Peter Thiel, Janus Henderson Investors, Medpace, GL Capital, JVC Investment Partners, and Presight Capital. The Company is investigating obicetrapib as the preferred LDL-c lowering therapy for patients with ASCVD/FH on maximally tolerated statin therapy as well as for the treatment of Alzheimer’s disease and diabetes. NewAmsterdam Pharma is headquartered in Naarden, The Netherlands. For more information, please visit: www.newamsterdampharma.com
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