- New positive data for obicetrapib in patients with dyslipidemia who are currently taking high-intensity statin (HIS) therapy further confirm genetic validation of CETP in LDL-lowering
- Primary endpoint was met for both 5mg and 10mg doses; on top of HIS therapy obicetrapib reduced median LDL-c Levels by 42% and 51% from baseline, respectively
- Obicetrapib was safe and well tolerated in both study cohorts
NewAmsterdam Pharma (NAP), a clinical-stage company focused on the research and development of transformative therapies for metabolic diseases, today announced full results from its Phase 2 Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (ROSE). The results were presented at the 2021 American Heart Association (AHA) Scientific Sessions by Professor Stephen Nicholls, M.D., Director of MonashHeart, Monash Health and Professor of Cardiology, Monash University, Australia. Obicetrapib is an investigational, novel, selective cholesteryl ester transfer protein (CETP) inhibitor. NAP is developing obicetrapib as an adjunct to maximally tolerated statin therapy, in a fixed-dose combination with ezetimibe and as a monotherapy.
"Statins are the most widely used therapy worldwide today to reduce LDL-c levels, and despite treatment with high-intensity statins (HIS), two thirds of patients at high risk for cardiovascular disease do not reach their target LDL-c level," said Professor Stephen Nicholls, M.D., Principal Investigator for the ROSE study and Director of Monash Health and Professor of Cardiology, Monash University, Australia. "The results presented today demonstrate a compelling rationale for considering obicetrapib as an adjunct to statin therapy to help bridge this unmet medical need."
Results from the ROSE study of 120 participants demonstrated that patients on statin therapy who received 5mg of obicetrapib saw a reduction in LDL-c of 42% and patients who were part of the 10mg cohort experienced a 51% reduction versus baseline, while the placebo cohort experienced a 7% reduction versus baseline. Adverse events (AEs) were seen in 47.5% (19/40) of patients receiving placebo, versus 32.5% (13/40) in the 5mg cohort (32.5%) and 20% (8/40) in the 10mg cohort. There were no serious AEs in the two obicetrapib cohorts and two serious AEs in the placebo arm. Additionally, patients receiving either 5mg or 10mg of obicetrapib experienced increases in apolipoprotein A-I (APOA1) HDL levels of 45% and 48% respectively.
"These clinical data are tremendously exciting in that they confirm the genetic validation of CETP inhibition as an LDL-lowering mechanism and show the effect of obicetrapib is just as robust in patients on high-intensity statins as it is in patients who are statin-intolerant, which has been a core pillar of our company strategy for developing obicetrapib in cardiovascular diseases and other major diseases of high unmet need," said John Kastelein, M.D., Ph.D., F.E.S.C., chief scientific officer at NewAmsterdam Pharma. "As we have known for many years, there exists a substantial unmet medical need for patients to access a potent, oral, affordable therapy to help reduce LDL-c. We look forward to advancing our development program as we seek to initiate Phase 3 studies later this year."
"The data presented today at AHA Scientific Session reaffirm what Dr. Kastelein and I have sought to achieve over the past 20-plus years in our scientific research. With these data, we believe we have an orally available molecule that is safe, well tolerated, and can lower LDL-c, which may reduce major adverse cardiac events (MACE)," said Michael Davidson, M.D., chief executive officer at NewAmsterdam Pharma. "We are pleased with today's findings and are motivated to continue working with urgency to make obicetrapib a valuable addition for high risk ASCVD patients. To that end, we look forward to the next steps in the development of this important new therapy."
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 The Lancet), a randomized double-blind, placebo-controlled Phase 2a trial in 364 mildly dyslipidemic patients, which showed that obicetrapib is well-tolerated and lowers LDL-c up to 45% from baseline in patients as a monotherapy and up to 68% from baseline respectively in combination with moderate intensity statins therapy. 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 metabolic 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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