Shares in Intra-Cellular Therapies rose sharply after it reported that its only product Caplyta was effective for a new indication, major depressive disorder (MDD), in a phase 3 trial.

在一项3期临床试验中，据报道其唯一产品Caplyta对一种新的适应症重度抑郁症（MDD）有效后，细胞内治疗的份额急剧上升。

Caplyta (lumateperone) has been approved to treat schizophrenia since the end of 2019 and bipolar depression since 2021, with sales growing steadily to reach $462 million last year, easily matching analyst expectations in that use.

Caplyta（lumateperone）自2019年底以来被批准用于治疗精神分裂症，自2021年以来被批准用于治疗躁郁症，去年销售额稳步增长，达到4.62亿美元，很容易达到分析师对该用途的预期。

Adding MDD as an indication could unlock a big new market and drive the product to blockbuster revenue levels, and the new readout puts Intra-Cellular on course for its target of filing for approval in MDD before the end of the year.

添加MDD作为一个指示可能会打开一个巨大的新市场，并将产品推向轰动的收入水平，而新的读数将使Intra Cellular有望在年底前提交MDD审批。

Buoyed by the new data, Intra-Cellular promptly filed a $500 million stock offering to help fund what could be a big expansion of its business, along with additional trials of Caplyta in new indications like irritability associated with autism and a following R&D pipeline that includes therapies for Parkinson’s disease and cancer..

在新数据的鼓舞下，Intra Cellular迅速提交了一份价值5亿美元的股票发行申请，以帮助资助其业务的大规模扩张，同时还对Caplyta进行了额外的试验，以适应自闭症相关的烦躁不安等新适应症，以及随后的研发渠道，其中包括帕金森氏病和癌症的治疗。。

In the new trial, called Study 501, a once-daily oral dose of Caplyta or a matched placebo was given on top of regular antidepressants to 485 patients who were unable to get sufficient benefit from one of two standard therapies.

在名为研究501的新试验中，485名无法从两种标准疗法之一中获得足够益处的患者，在常规抗抑郁药的基础上，每天口服一次Caplyta或匹配的安慰剂。

The primary endpoint in the study was the change in the Montgomery–Åsberg Depression Rating Scale (MADRS) at week six, with Caplyta showing a 14.7-point improvement versus 9.8 points for placebo.

该研究的主要终点是蒙哥马利-Åsberg抑郁评定量表（MADRS）在第六周的变化，Caplyta显示出14.7分的改善，而安慰剂组为9.8分。

That 4.9-point difference was comfortably above a 2- to 4-point range highlighted by Intra-Cellular’s chief executive Dr Sharon Mates on an earlier conference call as what might be expected from the study.

这一4.9分的差距远远超过了Intra Cellular首席执行官Sharon Mates博士在早些时候的一次电话会议上强调的2到4分的范围，这可能是该研究所期望的。

All eyes now turn to Study 502, a second phase 3 trial of Caplyta as an adjunctive therapy for MDD which is due to generate results in the next few months and – if positive – will support marketing applications.

现在所有的目光都转向研究502，这是Caplyta作为MDD辅助治疗的第二个3期临床试验，预计将在未来几个月产生结果，如果阳性，将支持营销应用。

Caplyta is a first-in-class drug that acts on three neurotransmitter systems – dopamine, serotonin and glutamate – and seems to have a faster onset of action than conventional antidepressant drugs which can take weeks to have a mood-elevating effect.

Caplyta是一种一流的药物，作用于多巴胺、血清素和谷氨酸三种神经递质系统，似乎比传统的抗抑郁药起效更快，而传统的抗抑郁药可能需要数周才能产生情绪提升作用。

That rapid-acting property helped Johnson & Johnson claim FDA approval for its nasal spray antidepressant Spravato (esketamine) in 2019 for treatment-resistant depression, despite mixed results in trials. Last year, Spravato grew more than 80% to $689 million, showing the potential in the category.

尽管试验结果参差不齐，但这种速效特性帮助强生公司于2019年申请FDA批准其鼻喷雾剂抗抑郁药Spravato（esketamine）用于治疗耐药性抑郁症。去年，Spravato的销售额增长了80%以上，达到6.89亿美元，显示出该领域的潜力。

Another recent entrant is AbbVie’s Vraylar (cariprazine), which also started out as a treatment for schizophrenia and bipolar disorder and added adjunctive therapy of MDD to its label in 2022. Sales leapt by more than a third to $2.8 billion last year after that approval, while another candidate approved around that time promising rapid action – Axsome’s Auvelity (dextromethorphan/bupropion) – made $130 million.

另一个最近的参赛者是AbbVie的Vraylar（卡利嗪），它也开始用于治疗精神分裂症和双相情感障碍，并于2022年在其标签上增加了MDD的辅助治疗。在获得批准后，去年的销售额跃升了三分之一以上，达到28亿美元，而另一位候选人大约在那个时候批准了快速行动的承诺-Axsome的Auvelity（右美沙芬/安非他酮）-赚了1.3亿美元。

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Meanwhile, emerging candidates include J&J’s seltorexant and Relmada’s REL-1017 (dextromethadone) which are in phase 3 trials. Another potential rival is Sage Therapeutics/Biogen’s Zurzuvae (zuranolone), although that was approved by the FDA only for post-partum depression last year, with the MDD indication rejected..

与此同时，新出现的候选药物包括强生公司的seltorexant和Relmada公司的REL-1017（右美沙酮），它们正在进行3期试验。另一个潜在的竞争对手是Sage Therapeutics/Biogen的Zurzuvae（zuranolone），尽管去年FDA仅批准用于产后抑郁症，MDD适应症被拒绝。。