NewAmsterdam’s Obicetrapib Hits Primary Endpoint in Phase III HeFH Study, but Falls Short of Expectations

1. Primary Endpoint Met: NewAmsterdam Pharma's CETP inhibitor obicetrapib met its primary endpoint in the Phase III BROOKLYN trial, significantly reducing LDL cholesterol levels in patients with heterozygous familial hypercholesterolemia (HeFH).
2. LDL Cholesterol Reduction: Obicetrapib reduced LDL cholesterol by 36.3% at day 84 and 41.5% at day 365 compared to placebo, with more than half of patients achieving LDL levels below 70 mg/dL.
3. Safety Profile: The drug was well-tolerated, with no significant difference in treatment-emergent adverse events compared to placebo and a lower discontinuation rate.
4. Expectations Missed: Despite meeting the primary endpoint, the results fell short of investor and analyst expectations, leading to a decline in NewAmsterdam's shares.
5. Future Studies: The company is conducting four late-stage trials, including a study in patients with atherosclerotic cardiovascular disease, with results expected by the end of the year.