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百时美施贵宝备受瞩目的精神分裂症药物在测试中受挫

Bristol Myers’ prized schizophrenia drug stumbles in testing

BioPharma Dive 等信源发布 2025-04-24 06:50

可切换为仅中文


A brain drug at the center of a recent $14 billion acquisition has failed a large clinical trial, leading some Wall Street analysts to substantially lower their sales forecasts.

最近一项价值140亿美元的收购案核心的大脑药物未能通过大型临床试验,导致一些华尔街分析师大幅下调对其的销售预期。

Bristol Myers Squibb closed a deal to

百时美施贵宝达成了一项交易

acquire the drug, Cobenfy

获取药物,Cobenfy

, and its developer

,及其开发者

in March of last year

去年三月

, about six months before it was

,大约在它出现前的六个月

approved in the U.S.

美国批准

as a schizophrenia therapy. While launching Cobenfy, Bristol Myers has simultaneously been working to get the drug cleared for other uses, such as adding it on top of atypical antipsychotics for the treatment of schizophrenia.

作为精神分裂症的治疗方法。在推出Cobenfy的同时,百时美施贵宝公司一直在努力使该药物获得其他用途的批准,例如将其与非典型抗精神病药物联合使用以治疗精神分裂症。

But that work has now hit a setback. On Tuesday afternoon, Bristol Myers disclosed that an almost 400-person study found its drug

但这项工作现在遇到了挫折。周二下午,百时美施贵宝披露了一项近 400 人的研究,发现其药物

not significantly better than a placebo

并不比安慰剂显著更好

in this setting.

在这种设定下。

All participants in the study were given atypical antipsychotics, with about half taking Cobenfy and the other half a placebo. Using a well-known, 210-point scale that measures the severity of schizophrenia symptoms, researchers found scores in the Cobenfy group improved by 14.3 points. Though that change was roughly two points better than the placebo arm, it wasn’t enough to hit the trial’s main goal..

所有参加研究的人员都服用了非典型抗精神病药物,其中约一半人服用Cobenfy,另一半人服用安慰剂。研究人员使用一个知名的210分制量表来衡量精神分裂症症状的严重程度,发现Cobenfy组的得分改善了14.3分。尽管这一变化比安慰剂组好了约两分,但这还不足以达到试验的主要目标。

Bristol Myers said it will further analyze the results and discuss them with regulators and the medical community. The company also plans to present more detailed data at an upcoming medical conference.

百时美施贵宝表示,将进一步分析结果,并与监管机构和医学界讨论。该公司还计划在即将召开的医学会议上展示更详细的数据。

'When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult,” said Husseini Manji, a professor in Oxford University’s psychiatry department and co-chair of the U.K. government’s Mental Health Goals program, in a statement from Bristol Myers..

“当患者已经在接受治疗时,证明额外的统计学益处本身就变得更加困难,”牛津大学精神病学系教授、英国政府心理健康目标计划联合主席胡赛尼·曼吉在百时美施贵宝的一份声明中表示。

“Although Cobenfy did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging,” Manji added. “These findings warrant additional follow up and may provide valuable direction in our ongoing search for complementary approaches to address these persistent treatment gaps.”.

“尽管在这项试验中,Cobenfy作为辅助治疗并未显示出具有统计学意义的改善,但数据令人鼓舞,”曼吉补充道。“这些发现值得进一步跟进,可能为我们在持续寻找解决这些长期治疗缺口的补充方法上提供有价值的指导。”

Analysts view Cobenfy as a vital revenue driver for Bristol Myers, which stands to

分析师认为,Cobenfy对百时美施贵宝来说是一个重要的收入驱动力,它将

lose patent protection

失去专利保护

on two of its most lucrative products — the blood thinner Eliquis and the cancer immunotherapy Opdivo — in a few years. Yet the trial failure has some rethinking Cobenfy’s commercial outlook. David Risinger, an analyst at Leerink Partners, previously predicted that Cobenfy revenue would reach $5.8 billion in 2030.

在接下来的几年里,这两种最赚钱的产品——血液稀释剂艾乐妥和癌症免疫疗法欧狄沃。然而,试验的失败使一些人重新考虑了科贝奈的商业前景。李文克合伙公司的分析师大卫·莱辛格此前预测,科贝奈在2030年的收入将达到58亿美元。

Now, he has cut that forecast to $2.6 billion..

现在,他已经将这一预测削减至26亿美元。

In a note to clients, Risinger claimed the failure indicates Cobenfy is only modestly effective, igniting fears among his team that the drug has “far less potential than we originally anticipated.”

在给客户的一份报告中,Risinger 声称此次失败表明 Cobenfy 的效果平平,这引发了其团队对这种药物“潜力远不如我们最初预期”的担忧。

Sean McCutcheon, from the investment bank Raymond James, lowered his 2030 estimates, too, from a little over $3.7 billion to a little under $3 billion. He also removed the adjuvant schizophrenia opportunity from his model.

来自投资银行Raymond James的肖恩·麦卡琴也将其2030年的预测从略高于37亿美元下调至略低于30亿美元。他还从模型中移除了辅助精神分裂症的机会。

According to McCutcheon, perhaps the biggest consequence of the study failure is that it might increase the perceived risk of Cobenfy succeeding in the “myriad” other conditions in which it’s being tested. Those include bipolar disorder, autism spectrum disorder and symptoms associated with Alzheimer's disease like agitation and psychosis..

根据麦克切恩的说法,这项研究失败的最大后果可能是,它可能会增加外界对Cobenfy在其他“众多”测试条件中成功的感知风险。这些条件包括双相情感障碍、自闭症谱系障碍以及与阿尔茨海默病相关的症状,如躁动和精神病。

Others, though, don’t appear as worried. William Blair analyst Matt Phipps still sees a “significant commercial opportunity” for the drug in schizophrenia and, potentially, Alzheimer’s psychosis. And Carter Gould, of Cantor Fitzgerald, argues the trial’s outcome isn’t as dire as it might seem. Bristol Myers said there were underlying trends favoring Cobenfy, for example..

不过,其他人似乎并不那么担忧。威廉布莱尔分析师马特·菲普斯仍然认为该药物在精神分裂症,甚至可能是阿尔茨海默病精神病方面存在“显著的商业机会”。康托尔菲茨杰拉德的卡特·古尔德则认为,试验结果并不像看上去那么糟糕。百时美施贵宝表示,有一些潜在趋势对Cobenfy有利,例如。

In his own client note, Gould also highlighted how not only was Cobenfy already being used as an adjuvant schizophrenia treatment ahead of the trial results, but feedback given to the Cantor team from some influential doctors suggested they would keep prescribing the drug even if it missed in this setting..

在高德自己的客户报告中,他还强调,不仅科本菲已经在试验结果出来之前就被用作辅助精神分裂症治疗药物,而且一些有影响力的医生向康托团队提供的反馈表明,即使在这种情况下该药物未能达到预期效果,他们仍会继续开这种药。

“Bigger picture, the optics around a negative top-line result for one of the bright spots in the commercial portfolio aren’t great, but there’s likely enough here on efficacy for psychiatrists to justify continued and growing use of the drug in schizophrenia,” Gould wrote.

“从更大的角度来看,商业组合中一个亮点出现负面头条结果的 optics 并不理想,但这里可能有足够的疗效数据,足以让精神科医生证明继续并增加该药物在精神分裂症中的使用是合理的,”戈尔德写道。

Shares of Bristol Myers were down 4%, to about $48 apiece, in pre-market trading on Wednesday.

周三盘前交易中,百时美施贵宝的股价下跌了4%,至每股约48美元。