NewAmsterdam Pharma Doses First Patient in Phase 3 BROADWAY Trial of Obicetrapib in Adults with Heterozygous Familial Hypercholesterolemia and/or Established Atherosclerotic Cardiovascular Disease
Study evaluates obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor, as an adjunct to diet and maximally tolerated lipid-lowering therapy
Company is expected to complete enrollment in 2022 and announce data in the first quarter of 2024
Naarden, the Netherlands, January 4, 2022 -- 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 its Phase 3 BROADWAY trial of obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor. BROADWAY is a placebo-controlled, double-blind, randomized study as an adjunct to diet and maximally tolerated lipid-lowering therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) and/or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low‑density lipoprotein cholesterol (LDL-c). Today’s announcement follows a recent data presentation at the 2021 AHA Scientific Sessions of NewAmsterdam’s Phase 2 ROSE trial, which met its primary endpoint in reducing LDL-c.
“We are thrilled to initiate our Phase 3 BROADWAY trial,” said Michael Davidson, MD, chief executive officer of NewAmsterdam Pharma. “With this study, we are confident that we will continue generating compelling data around the benefit of obicetrapib—a simple, low-dose, once daily oral therapy—for patients at risk for cardiometabolic diseases. We look forward to providing additional updates as our clinical program progresses.”
The primary objective of the BROADWAY trial is to evaluate the effect of obicetrapib on LDL-c levels at day 84. Secondary objectives include evaluating the effect of obicetrapib on apolipoprotein B (ApoB), non-high density lipoprotein cholesterol (HDL-c), HDL-c, total cholesterol and triglycerides at day 84, and on LDL-c levels at days 180 and 365. The trial will also be evaluating the safety and tolerability profile of obicetrapib.
A total of 2,400 patients will be randomized to placebo or 10 mg obicetrapib dosed as a once daily oral treatment for a 52-week treatment period. Enrollment is expected to be completed in the fourth quarter of 2022.
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 TULIP[1] 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
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
[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