Supernus Pharmaceuticals, Inc.

Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms Suicidal ideation decreased by 80% SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression Oct. 31, 2024 -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced data in a poster presentation at Psych Congress 2024 with new data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder (MDD). The study examined the safety and tolerability of 2400 mg of SPN-820 given once every three days as an adjunctive treatment to the current baseline antidepressant therapy and assessed the rapid onset of improvement in depressive symptoms. The study included 40 enrolled subjects, of which 38 completed the 10-day treatment period. In the Phase 2a study, SPN-820 demonstrated a clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 items (HAM-D6), as well as a clinically meaningful improvement of -16.6 at four hours and -22.9 at Day 10 on the Montgomery Åsberg Depression Rating Scale (MADRS). New data from the Phase 2a study presented at Psych Congress 2024 demonstrate a rapid MADRS response rate (≥50% reduction) and remission (MADRS ≤10), reaching 50.0% and 35.0% of participants, respectively, at 4 hours, with additional improvement to 84.2% and 63.2% by Day 10. Suicidal ideation decreased by 80% (from 12.5% with suicidal ideation at baseline to 2.6% with suicidal ideation at Day 10). SPN-820 was well-tolerated with few adverse events (AEs) and had acceptable tolerability with a low discontinuation rate due to AEs (2.5%). Most common AEs related to the drug were mild to moderate and included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed and considered mild to moderate. There were no severe AEs and no serious AEs reported. “The data shared at the Psych Congress suggest the promise of SPN-820 as a potential first-in-class, novel treatment option for patients with depression, in which it demonstrated rapid acting antidepressant properties, a favorable tolerability profile and convenient, oral at home administration,” said Jonathan Rubin, M.D., Chief Medical Officer and Senior Vice President, Research & Development, Supernus Pharmaceuticals. “By decreasing symptoms safely and effectively without certain burdensome side effects, with a majority of patients reaching a remission threshold in just 10 days, SPN-820 exhibited meaningful improvements on the main depression rating scales, and we remain very excited about its potential to make a difference in the lives of those suffering from depression.” SPN-820 is a first-in-class, orally active small molecule that modulates the brain mechanistic target of rapamycin complex 1 (mTORC1), increasing synaptic function via an intracellular mechanism. SPN-820 is being developed to provide a rapid-onset antidepressant response via oral administration for adult patients with depression. The compound has a novel mechanism of action that enhances synaptic activity and cellular metabolism in the brain and has demonstrated a rapid onset of action (signal at two hours) in early clinical studies. SPN-820 is expected to provide rapid antidepressant efficacy without dissociative side effects. A Phase 2b clinical study of SPN-820 in approximately 227 adult patients with treatment-resistant depression is ongoing. The study is a Phase 2a open-label study in 40 subjects with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy and safety. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel, first in class CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. The content above comes from the network. if any infringement, please contact us to modify.

▎药明康德内容团队编辑 日前，Supernus Pharmaceuticals公布其潜在“first-in-class”在研小分子疗法SPN-820用以治疗抑郁症（MDD）成人患者的探索性开放标签2a期临床研究的积极数据。分析显示，接受该疗法治疗的MDD患者的自杀意念减少了80%。目前一项评估SPN-820用于治疗约227名难治性抑郁症成人患者的2b期临床研究正在进行中。 这次所公布的2a期研究检视了每三天使用一次2400毫克SPN-820作为抗抑郁基础治疗的辅助疗法的安全性和耐受性。该研究纳入了40名受试者，其中38名完成了10天的治疗期。 这次公布的新数据表明，SPN-820的疗效迅速，患者接受治疗4小时后，分别有50.0%和35.0%的患者产生蒙哥马利阿斯伯格抑郁量表（MADRS）所评估的应答（评分减少≥50%）和MADRS缓解（MADRS评分≤10）。此数值到第10天则进一步改善至84.2%和63.2%。此外，患者的自杀意念减少了80%（从基线时的12.5%到第10天时的2.6%）。SPN-820的耐受性良好，不良事件（AE）很少，因AE导致的停药率低（2.5%）。 SPN-820是一款在研、潜在“first-in-class”的口服小分子疗法，可调节大脑中雷帕霉素复合物1（mTORC1）靶点，通过细胞内机制增强突触功能。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Supernus Presents Promising Data from Open-Label Phase 2a Study of SPN-820 Data in Major Depressive Disorder at Psych Congress 2024. Retrieved November 1, 2024 from https://www.globenewswire.com/news-release/2024/10/31/2973042/19871/en/Supernus-Presents-Promising-Data-from-Open-Label-Phase-2a-Study-of-SPN-820-Data-in-Major-Depressive-Disorder-at-Psych-Congress-2024.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

Supernus Pharmaceuticals公司今日公布了潜在“first-in-class”疗法SPN-820在抑郁症（MDD）成人患者中的探索性开放标签2a期临床研究的数据。该研究考察了每三天一次SPN-820（2400 mg）作为当前基础抗抑郁治疗的辅助疗法的安全性和耐受性，并评估了其对抑郁症状的快速改善效果。试验结果显示，SPN-820在几小时内可迅速改善患者抑郁症状，并且效果维持到为期10天的研究结束时。 此次试验结果分析包含40名受试者，其中38人完成了为期10天的治疗周期。主要分析结果显示： 在汉密尔顿抑郁量表6项评分（HAM-D6）上，患者接受治疗两小时后的总评分改善了6.1，10天后改善了9.6，达到了临床上有意义的改善。 在蒙哥马利-阿斯伯格抑郁量表（MADRS）上，患者接受治疗四小时后的总评分改善了16.6，10天后改善了22.9，达到了临床上有意义的改善。 患者自杀意念减少了80%（基线时有12.5%的受试者报告自杀意念，10天后这一比例降至2.6%）。 SPN-820耐受性良好，不良事件（AE）较少，因不良事件导致的停药率为2.5%。与药物相关的最常见不良事件包括头痛、恶心、嗜睡和头晕。其他观察到的不良事件包括认知障碍、口干、疲劳、鼻塞和口腔感觉异常。 SPN-820是一种潜在“first-in-class”的口服小分子药物，它通过增加大脑内mTORC1介导的突触功能来发挥作用。该化合物具有一种新颖的作用机制，可以增强大脑中的突触活动和细胞代谢，并在早期临床研究中表现出快速起效的特性（两小时内出现疗效信号）。SPN-820预计能够提供快速的抗抑郁疗效，同时避免潜在的副作用。目前，SPN-820正在进行随机双盲，含安慰剂对照的2b期临床试验，治疗难治性抑郁症患者，预计在2025年上半年公布主要结果。 参考资料： [1] Supernus Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder. Retrieved October 18, 2024, from https://ir.supernus.com/news-releases/news-release-details/supernus-announces-promising-data-open-label-phase-2a-study-spn [2] SPN-820 Phase 2a Study. Retrieved October 18, 2024, from https://ir.supernus.com/static-files/ab65cf23-b874-4b16-819b-13eb197962e7 内容来源于网络，如有侵权，请联系删除。