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Why Is Vertex Pharmaceuticals Stock Trading Lower On Thursday After Back Pain Trial Data?

Why Is Vertex Pharmaceuticals Stock Trading Lower On Thursday After Back Pain Trial Data?

为什么福泰制药的股票在周四因背痛试验数据而下跌?
Benzinga ·  12/19 13:06

On Thursday, Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced results from its Phase 2 study of suzetrigine for painful lumbosacral radiculopathy (LSR), a disorder that causes pain in the lower back and hip that radiates down the back of the thigh into the leg.

周四,福泰制药(纳斯达克:VRTX)公布了其针对疼痛性腰骶神经根痛(LSR)的苏泽曲因二期研究结果,LSR是一种导致下背部和髋部疼痛的疾病,这种疼痛会放射到大腿后部并延伸到腿部。

The study met its primary endpoint with a statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).

该研究达到了其主要终点,在数字疼痛评分量表(NPRS)上显示出统计学显著且临床意义重大的疼痛减少。

The suzetrigine arm showed a statistically significant and clinically meaningful within-group reduction in pain from baseline, with a mean change in NPRS at Week 12 of -2.02.

苏泽曲因组在基线的组内疼痛减少显示出统计学显著且临床意义重大的结果,12周时NPRS的平均变化为-2.02。

Also Read: Vertex Has $5 Billion-Plus Opportunity In Pain And Kidney Disease Programs, Analyst Upgrades Stock

另请阅读:分析师升级股票,福泰制药在疼痛和肾病项目中拥有超过50亿的机会。

The study also included a placebo reference arm, which showed a similar within-group reduction in pain from baseline, with a mean change in NPRS at Week 12 of -1.98.

该研究还包括一个安慰剂参考组,该组在基线的组内疼痛减少也显示出类似情况,12周时NPRS的平均变化为-1.98。

Secondary and other endpoints were consistent with the study's primary endpoint.

次要和其他指标与研究的主要指标一致。

Vertex also conducted post-hoc analyses showing variability in the placebo response across study sites, a recognized issue in pain trials.

福泰制药还进行了后期分析,显示出研究地点间安慰剂反应的变异性,这是疼痛试验中公认的问题。

In the ~40% of sites that had lower placebo responses, the suzetrigine arm within-group reduction in pain was similar to the overall study and had greater separation from the placebo arm.

在~40%安慰剂反应较低的地点,苏泽曲因组的组内疼痛减少与整个研究相似,并且与安慰剂组的分离程度更大。

These analyses suggest that trial design innovation may better control the placebo response and separate the treatment effect of suzetrigine from placebo in future studies, which Vertex will incorporate as it designs the pivotal program.

这些分析表明,试验设计的创新可能更好地控制安慰剂反应,并在未来的研究中将苏泽曲丁的治疗效果与安慰剂区分开来,福泰制药将在设计关键程序时纳入这一点。

Suzetrigine was generally well tolerated in the study. William Blair notes that Vertex plans to move suzetrigine into Phase 3 trials following discussions with regulators despite Phase 2 results not clearly outperforming a placebo.

在这项研究中,苏泽曲丁的耐受性总体良好。威廉·布莱尔指出,尽管第二阶段的结果未明显优于安慰剂,福泰制药仍计划在与监管机构讨论后将苏泽曲丁推进至第三阶段试验。

The analyst questions the decision, citing concerns about the trial's design and the small effect size, which could make it hard to ensure success.

分析师质疑这一决定,引用试验设计和小效应量的担忧,这可能导致确保成功的难度。

Price Action: VRTX stock is down 13.4% at $387.37 at last check Thursday.

价格动态:VRTX股票在上周四最后检查时下跌了13.4%,报每股387.37美元。

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