Editor’s Note: This article has been corrected to accurately refer to the drug name as obicetrapib in reference to the discontinuation rate.
On Monday, NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) released topline data from the Phase 3 BROOKLYN clinical trial, the first of four studies to evaluate obicetrapib in heterozygous familial hypercholesterolemia (HeFH) patients, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
The BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36.3% (p < 0.0001) compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of 41.5% (p < 0.0001).
The observed reductions in other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB), met statistical significance.
In the trial, obicetrapib was observed to be well-tolerated, with safety results comparable to placebo and no increase in blood pressure.
The treatment discontinuation rate for the obicetrapib arm was 7.6% versus 14.4% for the placebo.
Despite the trial hitting its primary endpoint, the company’s stock experienced volatility, closing 8.35% lower at $17.29 on Monday.
William Blair notes that investors debate the read-through of BROOKLYN to the ongoing BROADWAY and PREVAIL trials.
The analyst highlights that though the LDL reductions came in a little below expectations, William Blair is still confident in obicetrapib’s ability to drive a 20% relative risk reduction (RRR) in outcomes in the PREVAIL study (roughly a 34% LDL reduction needed to reach 20% RRR).
The analyst reiterates the Outperform rating.
It is not unexpected to see LDL-C increase over time in HeFH patients, but the analyst expects less change over longer follow-up in BROADWAY and PREVAIL studies.
William Blair also states that the safety of obicetrapib looked strong, but highlights that this study’s small size makes it more cautious to over-interpret secondary endpoints like cardiovascular events.
Price Action: NAMS stock is down 1.97% at $16.91 at last check Tuesday.
Read Next:
Photo: Shutterstock
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
