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. 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.
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