NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of MM120 (lysergic acid diethylamide [LSD] D-tartrate) into pivotal trials for the treatment of adults with GAD..

纽约--（商业新闻短讯）--Mind Medicine（MindMed）Inc.（纳斯达克：MNMD）（“公司”或“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，今天宣布完成与美国食品和药物管理局（FDA）的第二阶段（EOP2）会议的结束，支持将MM120（麦角酸二乙酰胺[LSD]D-酒石酸盐）推进治疗成人GAD的关键试验。。

“Following a constructive End-of-Phase 2 meeting with the FDA, we are pleased to have reached alignment on our Phase 3 development strategy for MM120 in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “This marks a significant milestone for MindMed and for the millions of individuals affected by GAD.

MindMed首席执行官罗伯·巴罗（RobBarrow）表示：“在与FDA的第二阶段会议建设性结束后，我们很高兴在GAD的MM120第三阶段发展战略上达成一致。”。“这对于MindMed和数百万受GAD影响的个人来说是一个重要的里程碑。

We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet (ODT) in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months.”.

我们计划于今年下半年在GAD启动MM120口服溶解片（ODT）的第三阶段临床计划，并期待在未来几个月分享我们关键计划设计的更多细节。”。

The EOP2 meeting was supported by results from MindMed’s completed Phase 2b clinical trial, MMED008. The multi-center, randomized, double-blind, parallel-group, dose-finding study was designed to assess the effect of four doses of MM120 for the treatment of anxiety symptoms in participants diagnosed with GAD.

EOP2会议得到了MindMed完成的2b期临床试验MMED008的结果的支持。这项多中心，随机，双盲，平行组，剂量发现研究旨在评估四种剂量的MM120对诊断为GAD的参与者焦虑症状的治疗效果。

In the trial, MM120 met its primary and key secondary endpoints and demonstrated a rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort.

在试验中，MM120达到了其主要和关键的次要终点，并在第4周和第12周表现出汉密尔顿焦虑评定量表（HAM-a）的快速，临床意义和统计学显着改善，临床缓解率为65%，在MM120 100μg队列中持续至第12周的临床缓解率为48%。

MM120 was generally well-tolerated in this trial, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug..

MM120在该试验中通常耐受性良好，大多数不良事件被评为轻度至中度，短暂性，并在给药当天发生，并且与试验药物的预期急性作用一致。。

“On behalf of the 20 million people in the U.S. – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on the data from the previously completed Phase 2b MMED008 trial,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed.

MindMed首席医疗官Daniel R.Karlin说：“代表美国2000万以及全世界数百万患有GAD的人，我们对MM120根据之前完成的2b期MMED008试验数据显示的治疗潜力感到无比兴奋。”。

“Few treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.”.

“很少有治疗方案在GAD中显示出强大的活性，最近一次FDA批准发生在2007年。我们致力于将MM120带给GAD患者，并很高兴进入我们发展计划的下一阶段。”。

About MM120

关于MM120

LSD (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, the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders..

LSD（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 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导致恐惧，持续焦虑和持续的不知所措感。它的特点是对日常事物过度、执着和不切实际的担忧。。

adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication 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 2007..

。这种诊断不足和服务不足的适应症与严重受损，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2007年。。

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..

MindMed在纳斯达克交易，代码为MNMD。。

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 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关于启动MM120潜在3期临床试验的时间以及公司候选产品的潜在益处的声明。

There can be no guarantees regarding the timing or results of the potential Phase 3 clinical trials for MM120 for the treatment of GAD or that, following any such trials, 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 its history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical.

无法保证MM120治疗GAD的潜在3期临床试验的时间或结果，或者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（包括其负现金流历史）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；与研发相关的困难；与临床试验或研究相关的风险；加强监管审查；早期产品开发；临床。