NewAmsterdam Pharma (NASDAQ: NAMS) stock surged over 30% on Tuesday following the release of positive topline data from its Phase 3 BROADWAY clinical trial. The trial evaluated the efficacy and safety of obicetrapib, an oral, once-daily CETP inhibitor, in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) who had inadequately controlled low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated lipid-lowering therapy.
ASCVD, a chronic condition characterized by plaque buildup in artery walls, restricts blood flow and increases the risk of heart attack and stroke. HeFH, an inherited disorder, leads to significantly elevated cholesterol levels from birth. Both conditions underscore the critical need for effective LDL-C lowering therapies. LDL-C, often referred to as “bad” cholesterol, is a key driver of cardiovascular disease.
The BROADWAY trial’s primary endpoint measured the percentage change in LDL-C from baseline to day 84, comparing obicetrapib 10 mg to a placebo. Results showed a statistically significant 33% reduction in LDL-C (p<0.0001) in the obicetrapib group, exceeding expectations.
Beyond LDL-C reduction, the trial also assessed major adverse cardiovascular events (MACE), including death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization. Encouragingly, obicetrapib demonstrated a 21% reduction in MACE compared to the placebo. This finding strengthens the potential of obicetrapib to significantly improve cardiovascular outcomes.
William Blair analysts expressed increased confidence in obicetrapib’s ability to achieve a greater than 20% relative risk reduction in MACE in the ongoing Phase 3 PREVAIL cardiovascular outcomes study, based on these positive BROADWAY results.
Furthermore, the observed changes in other biomarkers aligned with data from previous NewAmsterdam Pharma clinical trials. Obicetrapib exhibited a favorable safety profile, with comparable results to the placebo in measures like blood pressure. The treatment discontinuation rates were similar between the obicetrapib (11.1%) and placebo (12.4%) groups, indicating good tolerability.
These promising Phase 3 results position obicetrapib as a potential game-changer in the management of ASCVD and HeFH, offering a new treatment option for patients struggling to control their LDL-C. The significant reduction in LDL-C and the observed MACE benefit suggest that obicetrapib could meaningfully improve cardiovascular health and reduce the risk of life-threatening events. The market reacted enthusiastically to this news, driving NewAmsterdam Pharma’s stock price to $24.74, a 33.6% increase at Tuesday’s close. The company awaits further data from the ongoing PREVAIL study to confirm these positive findings and solidify obicetrapib’s place in the cardiovascular treatment landscape.
