Top-line data show durable LDL lowering with obicetrapib for adults with HeFH
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Key takeaways:
- Obicetrapib conferred sustained LDL lowering for patients with HeFH already on maximally tolerated lipid-lowering therapy.
- Obicetrapib demonstrated a similar safety profile to that of placebo.
Obicetrapib significantly reduced LDL vs. placebo in adults with heterozygous familial hypercholesterolemia and uncontrolled LDL, despite maximally tolerated therapy, according to the top-line results of the phase 3 BROOKLYN clinical trial.
As Healio previously reported, obicetrapib (NewAmsterdam Pharma), an investigational cholesteryl ester transfer protein (CETP) inhibitor, plus ezetimibe further reduced LDL in statin-treated patients with dyslipidemia, according to the results of the phase 2 ROSE trial.
The present BROOKLYN trial met its primary endpoint, with participants assigned to once-daily obicetrapib 10 mg achieving an average 36.3% LDL reduction compared with placebo sustained out to 84 days (P < .0001) and 41.5% at 1 year (P < .0001), according to a company press release.
Significant reductions in HDL, non-HDL, lipoprotein(a) and apolipoprotein B were also reported.
Obicetrapib was well tolerated, with safety similar compared with placebo.
In addition, the company reported proportionately fewer treatment-emergent adverse events in the study drug arm compared with placebo.
The company announced plans to present the full results of the BROOKLYN trial at an upcoming medical conference and publish the data in a major medical journal.
“Today’s announcement marks an important milestone for NewAmsterdam, the HeFH community, and CVD more broadly,” Healio | Cardiology Today Editorial Board Member Michael H. Davidson, MD, FACC, FACP, FNLA, CEO of NewAmsterdam Pharma and clinical professor of medicine and director of the Lipid Clinic at University of Chicago Medicine, said in the release. “Despite the widespread availability of lipid-lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets. Patients and their doctors need additional options. We are very excited about the results from our BROOKLYN trial and believe they support obicetrapib’s potential to significantly reduce LDL-C in a challenging patient population, over a duration of 1 year. Adverse events and discontinuations due to side effects were similar to placebo, consistent with what was observed in phase 2 studies. In the safety population, there was also no increase in blood pressure, nor any difference from placebo in liver enzymes, [high-sensitivity C-reactive protein] or renal function. We look forward to building on these results with top-line data from BROADWAY expected in the fourth quarter of 2024, and top-line data from TANDEM expected in the first quarter of 2025.”
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