NewAmsterdam Pharma Announces Positive Results from Phase 3 BROADWAY Trial for Obicetrapib in Cardiovascular Disease
Preview
NewAmsterdam Pharma has announced positive topline data from the pivotal Phase 3 BROADWAY clinical trial, which evaluated the efficacy and safety of obicetrapib in patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH). The trial achieved its primary endpoint, demonstrating a significant reduction in low-density lipoprotein cholesterol (LDL-C) compared to placebo. This reduction was observed on top of maximally tolerated lipid-modifying therapies, indicating that obicetrapib can be an effective add-on treatment for patients who are already on the best available therapies.Key highlights from the trial include:
A 33% reduction in LDL-C levels at day 84, which is a substantial improvement over the current standard of care.
The trial also achieved all co-primary endpoints, including a reduction in non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB), both of which are critical markers for cardiovascular risk.
The safety profile of obicetrapib was favorable, with no significant adverse events reported beyond those typically associated with lipid-lowering therapies.
These results suggest that obicetrapib could be a valuable new treatment option for patients with ASCVD and HeFH, potentially addressing the limitations of current LDL-lowering therapies. The positive outcomes from the BROADWAY trial are expected to support NewAmsterdam Pharma's efforts to seek regulatory approval for obicetrapib, which could provide a new and effective tool in the fight against cardiovascular disease.