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 new clinical data from post-hoc analyses of its Phase 2b Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (ROSE) clinical trial, showing that patients treated with obicetrapib were more likely to achieve low-density lipoprotein cholesterol (LDL-c) target guideline goals compared to patients treated with placebo. These data were presented in late-breaking oral presentations at the 90th European Atherosclerosis Society (EAS) Congress, May 22-25, 2022 in Milan, Italy and the 2022 National Lipid Association (NLA) Scientific Sessions, June 2-5, 2022 in Scottsdale, Arizona.
Evidence from observational studies conducted in the United States and Europe suggest that between 75% and 80% of very high-risk primary and secondary prevention patients fail to achieve their target guideline goals.1,2 In the new data presented at EAS and NLA, NewAmsterdam showed that 82.5% of patients treated with the 10mg dose of obicetrapib and high-intensity statin (HIS) therapy achieved the LDL-c target of <70 mg/dL, compared to 20% of patients treated with placebo, and 60% achieved the LDL-c target of <55 mg/dL, compared to 5% of patients treated with placebo. In previously reported data from the ROSE study, treatment with the 10mg dose of obicetrapib on top of HIS therapy reduced mean LDL-c levels by 51% from baseline.
“We are delighted to present post-hoc analyses from the ROSE clinical trial, which further support the potential of obicetrapib to solve a substantial unmet need in dyslipidemia,” said John Kastelein, M.D., Ph.D., FESC, chief scientific officer of NewAmsterdam Pharma. “Despite the widespread recognition that elevated levels of LDL-c are causal in cardiovascular disease, too many very high-risk primary and secondary prevention patients fail to achieve their target goals and remain at unacceptably high risk. Together, with the full data we presented last year, these new results suggest that obicetrapib has the potential to address the two primary goals of lipid-lowering therapy, offering patients a substantial reduction in absolute LDL-c levels and a greater chance of achieving recommended LDL-c targets, which is the key modifiable risk factor for reducing their chance of experiencing a major adverse cardiac event.”
Additionally, NewAmsterdam shared new post-hoc analyses demonstrating that 92.5% of patients treated with the 10mg dose of obicetrapib on top of HIS therapy achieved the apolipoprotein B (ApoB) target of <80 mg/dL, compared to 27.5% of patients treated with placebo, and 67.5% achieved the ApoB target of <65 mg/dL, compared to 10% of patients treated with placebo.
“As data continues to emerge from the ROSE trial, we become increasingly more confident in obicetrapib as a valuable addition for the millions of high-risk patients who remain underserved by existing prescription medicines,” said Michael Davidson, M.D., chief executive officer at NewAmsterdam Pharma. “We look forward to continuing to advance our broad clinical development program, including our three ongoing Phase 3 trials, as we aim to deliver obicetrapib as a safe, effective, and convenient, once-daily oral tablet for patients who cannot achieve their LDL-c goal on statins alone.”
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 TULIP3 randomized double-blind, placebo-controlled Phase 2 trials. Results from the ROSE trial, presented in November 2021 at the AHA Scientific Sessions, included observations 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 were observed to experience a 51% reduction versus baseline, while the placebo cohort was observed to experience a 7% reduction versus baseline. Both doses were observed to be 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 three Phase 3 trials, BROADWAY, BROOKLYN 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. Results from NewAmsterdam’s ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10mg experienced 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.
1Klimchak, A. C., Patel, M. Y., Iorga, Ş. R., Kulkarni, N., & Wong, N. D. (2020). Lipid treatment and goal attainment characteristics among persons with atherosclerotic cardiovascular disease in the United States. American journal of preventive cardiology, 1, 100010. https://doi.org/10.1016/j.ajpc.2020.100010
2 Ray, K. K., Molemans, B., Schoonen, W. M., Giovas, P., Bray, S., Kiru, G., Murphy, J., Banach, M., De Servi, S., Gaita, D., Gouni-Berthold, I., Hovingh, G. K., Jozwiak, J. J., Jukema, J. W., Kiss, R. G., Kownator, S., Iversen, H. K., Maher, V., Masana, L., Parkhomenko, A., … DA VINCI study (2021). EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. European journal of preventive cardiology, 28(11), 1279–1289. https://doi.org/10.1093/eurjpc/zwaa047
3 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