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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

儘管對研究結果反應褒貶不一,但分析師對NewAmsterdam Pharma的降膽固醇藥物充滿信心。
Benzinga ·  07/30 15:10

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

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