Analyst Confident In NewAmsterdam Pharma's Cholesterol Drug Despite Mixed Reactions To Study Results
Analyst Confident In NewAmsterdam Pharma's Cholesterol Drug Despite Mixed Reactions To Study Results
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.
納斯達克:NewAmsterdam Pharma Company N.V.(NAMS)於星期一發布了第三期BROOKLYN臨床試驗的最終數據,這是評估obicetrapib治療雜合子家族性高膽固醇血癥(HeFH)患者的四項研究之一,這些患者的LDL-C未經適當控制,儘管在最大耐受的降脂治療下。
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).
該試驗達到其主要終點,在第84天相對安慰劑組取得了36.3%的LS平均降低(p
Related: Cholesterol Player NewAmsterdam Pharma's Obicetrapib Is A Potential Blockbuster In Cardiovascular Market: Bullish Analyst Says.
相關:看好分析師表示,膽固醇領域的NewAmsterdam Pharma的obicetrapib是潛在的千萬美元級別的“大片”
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.
觀察到的其他生物標誌物的降低,包括高密度脂蛋白膽固醇(HDL-C),非HDL-C,脂蛋白(a)(Lp(a))和載脂蛋白b(ApoB),均達到了統計學顯著性。
In the trial, obicetrapib was observed to be well-tolerated, with safety results comparable to placebo and no increase in blood pressure.
在試驗中,觀察到obicetrapib耐受性良好,安全性結果與安慰劑相當,沒有增加血壓。
The treatment discontinuation rate for the anacetrapib arm was 7.6% versus 14.4% for the placebo.
anacetrapib組的治療中斷率爲7.6%,安慰劑組爲14.4%。
Despite the trial hitting its primary endpoint, the company's stock experienced volatility, closing 8.35% lower at $17.29 on Monday.
儘管試驗達到了其主要終點,但公司股票經歷了波動,週一收盤下跌8.35%至17.29美元。
William Blair notes that investors debate the read-through of BROOKLYN to the ongoing BROADWAY and PREVAIL trials.
William Blair指出,投資者正在就BROOKLYN對正在進行的BROADWAY和PREVAIL試驗的閱讀進行辯論。
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).
分析師強調,儘管LDL的降低略低於預期,William Blair仍有信心obicetrapib能夠在PREVAIL研究中推動20%的相對風險降低(需要大約34%的LDL降低才能達到20%的相對風險降低)。
The analyst reiterates the Outperform rating.
分析師重申“跑贏大盤”評級。
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.
HeFH患者的LDL-C隨着時間的推移增加並不意外,但分析師預計在BROADWAY和PREVAIL研究的更長時間的隨訪中變化會較小。
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.
William Blair還表示,obicetrapib的安全性看起來很強,但是強調該研究規模較小,更謹慎地進行二次終點分析如心血管事件。
Price Action: NAMS stock is down 1.97% at $16.91 at last check Tuesday.
股價走勢:截至上週二的最後一次驗證,NAMS股價下跌1.97%至16.91美元。
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Photo: Shutterstock
Photo: shutterstock