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As Regulators Gear Up To Decide On Bristol Myers' Schizophrenia Treatment, Neurocrine Biosciences' Data Disappoints Investors

As Regulators Gear Up To Decide On Bristol Myers' Schizophrenia Treatment, Neurocrine Biosciences' Data Disappoints Investors

当监管机构决定布里斯托尔·迈耶斯治疗精神分裂症的时候,神经分泌生物科学的数据令投资者失望。
Benzinga ·  08/28 11:16

Wednesday, Neurocrine Biosciences, Inc. (NASDAQ:NBIX) topline data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) in adults with schizophrenia.

周三,Neurocrine Biosciences, Inc. (纳斯达克:NBIX) 公布了其NBI-1117568 (NBI-'568)在成年精神分裂症患者中的2期临床研究顶线数据。

NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist.

NBI-'568是第一个调查中的口服媒体M4选择性激动剂。

The new data showed that the once-daily 20 mg dose of NBI-'568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group.

新数据显示,NBI-'568每日20毫克剂量在6周后将阳性与阴性综合症量表(PANSS)基线平均减少18.2分,而安慰剂组减少10.8分。

Also Read: Regulators Expected To Approve Innovative Schizophrenia Treatment From Bristol Myers, Karuna.

另请阅读:监管机构预计将批准Bristol Myers、Karuna的创新精神分裂症治疗。

That 7.5-point difference reached statistical significance with a p-value of p=0.011.

这7.5分的差异达到了统计学显著性,p值为p=0.011。

The company noted that none of the other three higher-dosing groups (30, 40, and 60 mg) reached statistical significance.

该公司指出其他三个剂量组(30、40和60毫克)均未达到统计学显著性。

William Blair notes that while this effect size is in line with what was demonstrated by Bristol Myers Squibb Co (NYSE:BMY) acquired Karuna's KarXT, the 7.5 delta versus placebo is lower than the 11.6 difference in the Phase 3 EMERGENT-2 study.

William Blair指出,尽管这种效应规模与Bristol Myers Squibb Co (纽交所:BMY) 收购Karuna的KarXt所展示的相符,但与安慰剂相比的7.5差异低于3期EMERGENt-2研究的11.6差异。

It was also lower than the 0.75 effect size and 11.6-point delta from placebo from the EMERGENT-1 Phase 2 study and the 12.7-point and 11.1-point improvement over placebo with AbbVie Inc's (formerly Cerevel's) (NYSE:ABBV) emraclidine.

它也低于EMERGENt-1 2期研究中的0.75效应规模和11.6点的差异,以及AbbVie Inc(前Cerevel)(纽交所:ABBV) 的emraclidine相对安慰剂的12.7点和11.1点改善。

"We do highlight that the placebo improvement of 10.8 points is greater than what was seen in prior Phase II studies of KarXT and emraclidine, which is unsurprising given potential expectation bias around a more well-validated mechanism and is more in line with prior studies of antipsychotics historically," William Blair analyst adds.

我们确实强调了安慰剂改善了10.8个点,这比之前对KarXt和emraclidine的Phase II研究所看到的更多,这并不奇怪,考虑到对一种更为验证证实的机制的潜在期望偏差,并且与历史上的其他抗精神病药物的研究相一致。"William Blair分析师补充道。

Price Action: NBIX stock is down 18.90% at $123.71 at the last check on Wednesday.

价格走势:NBIX股票在周三最后一次检查时下跌18.90%,至123.71美元。

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