NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (Cboe Canada MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD).

纽约--（商业新闻短讯）--Mind Medicine（MindMed）Inc.（纳斯达克：MNMD），（Cboe Canada MMED），“公司”或“MindMed”），一家临床阶段的生物制药公司，开发用于治疗大脑健康疾病的新型候选产品，今天宣布FDA已授予其MM120（麦角苷d-酒石酸盐）突破性指定广泛性焦虑症（GAD）治疗计划。

The Company also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12..

该公司还宣布，其对GAD中MM120的2b期研究达到了其关键的次要终点，12周的topline数据显示，在第12周观察到的活动具有临床和统计学意义上的持久性。。

MindMed previously announced rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, which was the trial’s primary endpoint. MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention..

MindMed之前宣布，与安慰剂相比，汉密尔顿焦虑量表（HAM-A）在第4周（试验的主要终点）有快速，临床意义和统计学显着的改善。MM120在监测的临床环境中以单剂量给药，无需额外的治疗干预。。

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” stated David Feifel, MD, PhD, Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute in La Jolla, California and an investigator in the MM120 study.

加利福尼亚大学精神病学荣誉退休教授David Feifel博士说：“我在精神病学领域进行了20多年的临床研究，并看到了许多正在开发的治疗焦虑症的药物的研究。MM120表现出快速而强大的疗效，单次给药后稳定持续12周，这真是了不起。”，圣地亚哥，加利福尼亚州拉霍亚前进党神经精神病学研究所所长，MM120研究的研究员。

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.”.

“这些结果表明MM120在治疗焦虑症方面具有潜力，我们这些每天努力缓解患者焦虑的人期待着看到未来3期试验的结果。”。

MM120 100 µg – the dose with optimal clinical activity observed in the trial – demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12 (p<0.004).

MM120 100µg（在试验中观察到的具有最佳临床活性的剂量）在第12周比安慰剂改善了7.7点（-21.9 MM120 vs.-14.2安慰剂；p<0.003 Cohen's d=0.81），临床缓解率为65%，临床缓解率为48%，持续到第12周。100µg剂量组的临床总体印象-严重程度（CGI-S）评分平均从4.8分提高到2.2分，代表在第12周从“明显生病”到“临界生病”的两类转变（p＜0.004）。

This clinical activity was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12..

这种临床活动很快，早在研究第2天就观察到，并且持久，在第4周至第12周之间的平均HAM-A或CGI-S评分进一步改善。。

Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy.

基于GAD治疗中未满足的医疗需求（尤其是对目前可用药物无反应或耐受的患者），以及MindMed进行的2b期和其他研究的初步临床数据，美国食品和药物管理局（FDA）已将MM120指定为GAD的突破性疗法。

The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024..

该公司计划在2024年上半年与FDA举行第二阶段会议，并在2024年下半年启动第三阶段临床计划。。

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed.

MindMed首席执行官兼董事罗伯特·巴罗（RobertBarrow）表示：“FDA决定将MM120指定为GAD的突破性治疗方法，我们2b期研究的耐久性数据进一步验证了这种治疗方法在解决GAD患者巨大未满足需求方面的重要潜在作用。”。

“We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”.

“我们致力于将MM120带给GAD患者，并发挥我们治疗严重脑部健康疾病的潜力。”。

In the Phase 2b study, known as MMED008, MM120 was generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug. The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis..

在称为MMED008的2b期研究中，MM120通常具有良好的耐受性，大多数不良事件被评为轻度至中度，短暂且在给药当天发生，并且与研究药物的预期急性作用一致。给药当天最常见的不良事件（高剂量组发生率至少为10%）包括幻觉，幻觉，欣快情绪，焦虑，思维异常，头痛，感觉异常，头晕，震颤，恶心，呕吐，感觉异常，瞳孔散大和多汗症。。

Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

在用MM120治疗之前，研究参与者在临床上逐渐减量，然后从任何抗焦虑或抗抑郁治疗中洗掉，并且在参与研究期间没有接受任何形式的研究相关心理治疗。

“As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy,” said Reid Robison, MD, Psychiatrist and Chief Clinical Officer at Numinus (TSX:NUMI) who has served as adjunct faculty at the University of Utah for the last 12 years and was an investigator in the MM120 study.

“作为一名临床医生和临床研究人员，我赞扬MindMed设计的这项研究，通过消除其他药物和心理治疗等混杂变量来分离MM120的作用，”Numinus（TSX:NUMI）精神病医生兼首席临床官里德·罗宾逊（Reid Robison）说在过去的12年中，他一直担任犹他大学的兼职教师，并且是MM120研究的研究员。

“It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.”.

“它给了我对数据的信心，积极的结果给了我希望，这可能会为我的患者带来有意义的益处。”。

The primary data analyses from MMED008 have been accepted for presentation at the American Psychiatric Association’s annual meeting, which will be held in New York on May 4-8, 2024. The study is also being submitted for publication in a leading medical journal.

MMED008的主要数据分析已被美国精神病学协会年会接受，该年会将于2024年5月4日至8日在纽约举行。这项研究也被提交给一家领先的医学杂志发表。

Conference Call and Webcast

电话会议和网络广播

MindMed management will host a webcast at 8:00 am ET today to discuss the Phase 2b results of MM120 in GAD. The webcast and slides will be accessible live under “News & Events” on the Investors page of the Company’s website at https://ir.mindmed.co/ or by clicking here. A replay of the event will be available on MindMed’s website.

MindMed管理层将于美国东部时间今天上午8:00主持网络广播，讨论MM120在GAD的2b期结果。该网络广播和幻灯片将在公司网站的投资者页面上的“新闻与事件”下进行现场访问https://ir.mindmed.co/或者单击此处。该活动的重播将在MindMed的网站上提供。

The webcast will be archived on the Company’s website for at least 30 days after the conference call..

会议结束后，网络广播将在公司网站上存档至少30天。。

About Generalized Anxiety Disorder (GAD)

关于广泛性焦虑症（GAD）

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S.

GAD是一种与严重损害相关的常见疾病，对数百万人产生不利影响。GAD会导致恐惧，持续焦虑和持续的不堪重负感。它的特点是对日常事物过度、执着和不切实际的担忧。大约占美国的10%。

adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004..

代表约2000万人的成年人目前患有GAD，这是一种诊断不足和服务不足的指征，与严重受损，工作成就降低和劳动力参与减少有关。尽管GAD带来了巨大的个人和社会负担，但在过去的几十年中，GAD的治疗几乎没有创新，最近一次新药批准发生在2004年。。

About MMED008

关于MMED008

MMED008 was a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score.

MMED008是一项多中心，平行，随机，双盲，安慰剂对照，剂量优化研究。该试验招募了198名参与者，他们被随机分配接受25、50、100或200µg剂量的MM120单次给药或安慰剂。该试验的完整分析集（FAS）包括194名受试者，这些受试者至少有一个有效的基线后汉密尔顿焦虑评定量表（HAM-A）评分。

Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The study's main objective was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 4. The key secondary objective of the study was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from Baseline to Week 8.

参加试验的受试者表现出严重的GAD症状（平均基线HAM-A评分约为30）。该研究的主要目的是通过HAM-A从基线到第4周的变化来确定四剂MM120与安慰剂的剂量-反应关系。该研究的主要次要目标是通过HAM-A从基线到第8周的变化来确定四剂MM120与安慰剂的剂量-反应关系。

Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, and other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (NCT05407064)..

单次给药后12周内测量的次要目标包括评估焦虑症状，安全性和耐受性，以及其他疗效和生活质量指标。有关该试验的更多信息，请访问MindMed网站（MindMed.co）或clinicaltrials.gov（NCT05407064）。。

About MM120

关于MM120

Lysergide is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders..

麦角苷是一种合成麦角胺，属于经典或5-羟色胺能迷幻药组，可作为人5-羟色胺-2A（5-羟色胺-2A[5-HT2A]）受体的部分激动剂。MindMed正在为GAD开发MM120（麦角苷D-酒石酸盐），麦角苷的酒石酸盐形式，并正在探索其在其他严重脑部健康疾病中的潜在应用。。

About MindMed

关于MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders..

MindMed是一家临床阶段的生物制药公司，开发用于治疗大脑健康疾病的新型候选产品。我们的使命是成为开发和提供治疗的全球领导者，为改善患者预后提供新的机会。我们正在开发一系列创新产品候选产品，有或没有急性知觉效应，针对在大脑健康障碍中起关键作用的神经递质途径。。

MindMed trades on NASDAQ under the symbol MNMD and on the Cboe Canada (formerly known as the NEO Exchange, Inc.) under the symbol MMED.

MindMed在纳斯达克以MNMD的符号交易，在加拿大芝加哥期权交易所（以前称为NEO Exchange，Inc.）以MMED的符号交易。

Forward-Looking Statements

前瞻性声明

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements.

本新闻稿中与公司有关的某些声明构成适用证券法含义内的“前瞻性信息”，具有前瞻性。前瞻性信息并非基于历史事实，而是基于当前对未来事件的预期和预测，因此存在风险和不确定性，这可能导致实际结果与前瞻性声明所表达或暗示的未来结果存在重大差异。

These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated upcoming milestones, and progress of trials and studies; results and timing of and reporting of full data from the Company’s Phase 2b clinical trial of MM120; timing of a potential End-of-Phase-2 meeting with the FDA; timing of the initiation of a potential Phase 3 clinical trial of MM120; and the potential benefits of the Company’s product candidates.

这些陈述通常可以通过使用前瞻性词语来识别，例如“将”、“可能”、“应该”、“可能”、“打算”、“估计”、“计划”、“预期”、“期望”、“相信”、“潜在”或“继续”，或其负面或类似的变化。本新闻稿中的前瞻性信息包括但不限于有关预期即将到来的里程碑以及试验和研究进展的声明；公司MM120 2b期临床试验的结果、时间安排和完整数据报告；与FDA举行潜在的第二阶段结束会议的时间安排；开始MM120潜在的3期临床试验的时间；以及公司候选产品的潜在利益。

There can be no guarantees regarding the results of the potential Phase 3 clinical trial or that, following any such trial, MM120 will receive the necessary regulatory approvals. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulatio.

无法保证潜在的3期临床试验的结果，也不能保证在任何此类试验之后，MM120将获得必要的监管批准。存在许多风险和不确定性，可能导致实际结果以及公司的计划和目标与前瞻性信息（包括负现金流的历史）中表达的计划和目标存在重大差异；有限的运营历史；未来损失的发生；额外资本的可用性；产品收入不足；遵守法律法规。