CAD-1883

诺华在2020年以210美元的预付款收购了神经科学领域的长期合作伙伴Cadent Therapeutics。然而，这次赌注似乎失败了，因为瑞士制药公司决定终止一项中期重度抑郁障碍项目。发言人通过电子邮件声明表示，在对现有数据进行效益-风险评估之后，决定搁置MIJ821用于有自杀意念的重度抑郁障碍患者的治疗。研究参与者并未发现新的或不断变化的安全信号。这项已停止的二期研究旨在评估NR2B负异构调节剂与标准护理治疗相结合，以快速减轻重度抑郁障碍症状。该试验原计划于今年7月结束，但尚不清楚是否实现了目标。在将近三年前收购Cadent Therapeutics时，诺华获得了该公司的CAD-9303和CAD-1883两个项目的所有权。CAD-9303是一种研究性精神分裂症药物，当时正处于一期试验阶段。然而，发言人证实诺华从未公开宣布将这两个项目纳入其产品线，并表示因为这两个项目的计划从未公布过，所以公司没有可以分享的更新信息。MIJ821留下了一种治疗耐药性抑郁症的适应症，自2015年收购Cadent Therapeutics以来，诺华一直在测试这个适应症。根据诺华的产品线，这种静脉注射药物目前正在进行二期试验，但该公司拒绝确认研究的进展情况。发言人表示，诺华制药公司将在10月24日举行的第三季度财报电话会议上公布最新的产品线。MIJ821是诺华公司正在开发的治疗多发性硬化症的唯一疗法。该公司的神经科学产品组合还注重于偏头痛、多发性硬化症、肌萎缩侧索硬化症、帕金森病、阿尔茨海默病、进行性核上性麻痹症和脊髓性肌萎缩症。本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！

The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. Novartis rolled the dice in 2020 with a $210 upfront acquisition of long-time neuroscience partner Cadent Therapeutics. But the bet seems to have come up empty, as the Swiss pharma discontinues a mid-phase major depressive disorder program.  The decision to shelve MIJ821 in patients with major depressive disorder (MDD) experiencing suicidal ideation with intent followed a “benefit-risk assessment of available data,” a spokesperson said in an emailed statement. “No new or changing safety signal was identified for study participants.” The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. According to ClinicalTrials.gov, the trial was set to wrap this past July. The spokesperson did not confirm if the study met its goal.  When Novartis acquired Cadent less than three years ago, the pharma took ownership of the company's crown jewel CAD-9303, an investigational schizophrenia med being studied in a phase 1 trial at the time, and movement disorder program CAD-1883.  However, neither one of the assets was ever publicly incorporated into Novartis' pipeline, the spokesperson confirmed to Fierce Biotech. Because plans were never announced for the two programs, the company didn't have an update to share on them, according to the Novartis spokesperson. That leaves one indication for MIJ821 in treatment-resistant depression, something Novartis has been testing since 2015—years before the acquisition—when it exclusively licensed the asset from Cadent. The intravenous injection is currently being tested in a phase 2 trial, according to Novartis’ pipeline, though the company declined to confirm the ongoing status of the study.  The Big Pharma will share an updated pipeline as part of its third-quarter earnings call on Oct. 24, the spokesperson said.  MIJ821 is Novartis’ only therapy in development for MDD. The rest of the company’s neuroscience portfolio focuses on migraines, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, progressive supranuclear palsy and spinal muscular atrophy.