CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) announced today topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of the investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD).

马萨诸塞州剑桥市。-（商业新闻短讯）--Sage Therapeutics，Inc.（纳斯达克：Sage）今天宣布了Prevent的topline结果，这是一项双盲，安慰剂对照的2期研究，研究口服药物dalzanemdor（Sage-718）治疗帕金森病（PD）轻度认知障碍（MCI）患者。

The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42. Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed..

先前的研究没有达到其主要终点，即在第42天，在韦氏成人智力量表第四版（WAIS-IV）编码测试评分中，每天服用一次达尔扎恩多尔与安慰剂的参与者与基线相比存在统计学显着差异。Dalzanemdor（SAGE-718）通常耐受性良好，并且没有观察到新的安全信号。。

“We are disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “We are thankful for the patients and healthcare professionals who participated in this research.

Sage Therapeutics首席执行官巴里·格林（BarryGreene）表示：“鉴于轻度认知障碍对帕金森病患者和家庭造成的巨大负担，我们对第二阶段先例研究的结果感到失望。“我们感谢参与这项研究的患者和医疗保健专业人员。

Although cognitive impairment is common in neurodegenerative disorders, the underlying pathophysiology and symptomatology in Parkinson’s disease is distinctive, and these results do not necessarily predict results with dalzanemdor in other neurodegenerative conditions. We look forward to the topline data readouts from the Phase 2 studies in Huntington’s disease and Alzheimer’s disease expected later this year.”.

尽管认知障碍在神经退行性疾病中很常见，但帕金森病的潜在病理生理学和症状学是独特的，这些结果不一定能预测达尔扎内姆多在其他神经退行性疾病中的结果。我们期待着今年晚些时候亨廷顿舞蹈病和阿尔茨海默氏病第二阶段研究的结果。”。

PRECEDENT Study Results

先例研究结果

The PRECEDENT Study was a double-blind, placebo-controlled Phase 2 study in people with MCI in PD. The study is designed to evaluate the safety and efficacy of dalzanemdor (SAGE-718) dosed over 6 weeks. A total of 86 participants were enrolled and randomized.

先例研究是一项针对帕金森病MCI患者的双盲安慰剂对照2期研究。该研究旨在评估达尔扎涅姆多（SAGE-718）在6周内给药的安全性和有效性。共有86名参与者入选并随机分组。

The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42.

先前的研究没有达到其主要终点，即在第42天，在韦氏成人智力量表第四版（WAIS-IV）编码测试评分中，每天服用一次达尔扎恩多尔与安慰剂的参与者与基线相比存在统计学显着差异。

Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed. A total of 48 participants experienced treatment emergent adverse events (TEAEs). The vast majority of TEAES were mild to moderate in severity.

Dalzanemdor（SAGE-718）通常耐受性良好，并且没有观察到新的安全信号。共有48名参与者经历了治疗紧急不良事件（TEAE）。绝大多数TEAE的严重程度为轻度至中度。

Analyses did not suggest any meaningful differences versus placebo in the other exploratory endpoints such as SCOPA-Cog.

分析没有表明在其他探索性终点（如SCOPA Cog）与安慰剂相比有任何有意义的差异。

Based on the data, the Company does not plan any further development of dalzanemdor (SAGE-718) in PD. The Company expects the following milestones for the dalzanemdor (SAGE-718) Phase 2 clinical development program in 2024:

根据数据，公司不计划在PD中进一步开发dalzanemdor（SAGE-718）。公司预计dalzanemdor（SAGE-718）2期临床开发计划将在2024年达到以下里程碑：

Mid-2024:

2024年年中：

Report topline data from SURVEYOR Study in people with HD cognitive impairment

报告HD认知障碍患者SURVEYOR研究的基线数据

Late 2024:

2024年末：

Report topline data from LIGHTWAVE Study in people with MCI and mild dementia in AD

报告来自光波研究的MCI和AD轻度痴呆患者的基线数据

Report topline data from DIMENSION Study in people with HD cognitive impairment

报告HD认知障碍患者维度研究的基线数据

Conference Call Information

电话会议信息

Sage will host a conference call and webcast today, Wednesday, April 17 at 8:00 a.m. ET to review the PRECEDENT study results. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website following the completion of the event and will be archived for up to 30 days..

Sage将于今天，4月17日星期三上午8:00主持电话会议和网络广播，以回顾先前的研究结果。现场网络直播可在Sage网站investor.sagerx.com的投资者页面上访问。活动结束后，将在Sage网站上提供网络直播的重播，并将存档长达30天。。

About dalzanemdor (SAGE-718)

关于dalzanemdor（SAGE-718）

Dalzanemdor (SAGE-718), a first-in-class investigational NMDA receptor positive allosteric modulator (PAM), is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, including Huntington’s disease (HD) and Alzheimer’s disease (AD). Sage is advancing a clinical program for dalzanemdor (SAGE-718) with multiple ongoing placebo-controlled Phase 2 studies across multiple disease areas, including its potential lead indication, cognitive impairment associated with HD, as well as cognitive impairment in AD.

Dalzanemdor（SAGE-718）是一流的研究性NMDA受体阳性变构调节剂（PAM），正在开发作为与NMDA受体功能障碍相关的认知障碍的潜在口服疗法，包括亨廷顿舞蹈病（HD）和阿尔茨海默病（AD）。Sage正在推进一项针对dalzanemdor（Sage-718）的临床计划，该计划涉及多个疾病领域的多项正在进行的安慰剂对照2期研究，包括其潜在的铅指征，与HD相关的认知障碍以及AD的认知障碍。

The Company is also conducting an open-label safety study in HD cognitive impairment..

该公司还在HD认知障碍方面进行开放标签安全性研究。。

About Sage Therapeutics

关于Sage Therapeutics

Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health.

Sage Therapeutics（纳斯达克股票代码：Sage）是一家生物制药公司，致力于提供改变生命的大脑健康药物的开创性解决方案，使每个人都能茁壮成长。Sage开发了仅有的两种FDA批准的产后抑郁症治疗方法，并正在推进一条强大的管道，以满足大脑健康方面未满足的需求。

Sage was founded in 2010 and is headquartered in Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X..

Sage成立于2010年，总部位于马萨诸塞州剑桥。有关更多信息，请访问www.sagerx.com，或在Facebook、LinkedIn、Instagram和X上与我们联系。。

Forward-Looking Statements

前瞻性声明

Various statements in this release concern future expectations, plans and prospects, including without limitation statements regarding: our expectations with respect to the timing of reporting of results from ongoing clinical trials of dalzanemdor; our belief in the unmet need for new treatment options for brain health disorders; the potential for positive results from ongoing studies of dalzanemdor in HD and AD, despite negative results from the PRECEDENT study in PD; our views regarding possible distinctions among indications as a result of the underlying pathophysiology and symptomatology in PD; our statements as to the potential for dalzanemdor in the treatment of cognitive impairment due to certain neurodegenerative diseases; and the mission, goals, opportunity and potential for our business.

本版本中的各种声明涉及未来的期望，计划和前景，包括但不限于以下声明：我们对达尔扎涅姆多正在进行的临床试验结果报告时间的期望；我们相信对大脑健康障碍新治疗方案的需求尚未得到满足；尽管PD的先例研究结果为阴性，但正在进行的HD和AD中dalzanemdor研究仍可能取得积极结果；由于PD的潜在病理生理学和症状学，我们对适应症之间可能存在差异的观点；我们关于dalzanemdor治疗某些神经退行性疾病引起的认知障碍的潜力的声明；以及我们业务的使命、目标、机会和潜力。

These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the results of our ongoing clinical studies of dalzanemdor in HD and AD may be negative like the results we announced today from the PRECEDENT study in MCI in PD; the possible distinctions among indications as a result of the underlying pathophysiology and symptomatology in PD may not prove to be relevant in the context of clinical trials of dalzanemdor; the ongoing studies of dalzanemdor may not meet their primary or key secondary endpoints; results of earlier trials in HD and AD may not be replicated in ongoing or futur.

这些声明构成前瞻性声明，该术语在1995年《私人证券诉讼改革法案》中有定义。这些前瞻性声明既不是对未来业绩的承诺，也不是对未来业绩的保证，并且受到各种风险和不确定性的影响，其中许多风险和不确定性超出了我们的控制范围，这可能导致实际结果与这些前瞻性声明中预期的结果存在重大差异，包括以下风险：我们正在进行的dalzanemdor在HD和AD中的临床研究结果可能是负面的，就像我们今天在PD MCI的先例研究中宣布的结果一样；由于PD的潜在病理生理学和症状学，适应症之间可能存在的区别可能与dalzanemdor的临床试验无关；dalzanemdor正在进行的研究可能无法达到其主要或关键的次要终点；HD和AD早期试验的结果可能不会在正在进行的或未来复制。