Transcend Therapeutics宣布 TSND-201治疗 PTSD的 IMPACT-1二期研究达到主要终点-动脉网

Transcend Therapeutics Announces Primary Endpoint Met in IMPACT-1 Phase 2 Study of TSND-201 in PTSD

CISION 等信源发布 2025-03-31 19:30

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Primary endpoint met, with TSND-201 demonstrating statistically significant placebo-adjusted CAPS-5 improvement of -9.64 points on Day 64 (p = 0.011)

主要终点达成，TSND-201 在第64天显示出统计学上显著的安慰剂校正CAPS-5改善，改善幅度为-9.64点（p = 0.011）。

TSND-201 demonstrated rapid improvements, with a statistically significant placebo-adjusted CAPS-5 improvement of -8.00 points on Day 10 (p = 0.012), with placebo-adjusted improvements remaining statistically significantly for the duration of the trial

TSND-201表现出快速改善，在第10天时，经安慰剂调整的CAPS-5评分显著降低了8.00点（p = 0.012），并且在试验期间，安慰剂调整后的改善持续保持统计学显著性。

Robust and statistically significant improvements were noted across multiple secondary endpoints on Day 64

在第64天的多个次要终点上观察到了显著且统计学上显著的改善。

TSND-201 was generally safe and well tolerated, with a safety profile consistent with its non-hallucinogenic pharmacology

TSND-201 通常安全且耐受性良好，其安全性与非致幻药理学特征一致。

Company plans to align with FDA on Phase 3 program for PTSD

公司计划与FDA就PTSD的第三阶段计划达成一致

NEW YORK

纽约

，

March 31, 2025

2025年3月31日

/PRNewswire/ --

Transcend Therapeutics

超越治疗学

, a clinical-stage biotechnology company that develops medicines to treat neuropsychiatric diseases, today announced positive results from the IMPACT-1 study (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD]). IMPACT-1 was a randomized, double-blind, placebo-controlled, Phase 2 clinical trial evaluating TSND-201 (methylone), a rapid-acting neuroplastogen, for the treatment of PTSD.

，一家临床阶段的生物技术公司，致力于开发治疗神经精神疾病的药物，今天宣布了IMPACT-1研究（甲基酮用于创伤后应激障碍 [PTSD] 的研究）的积极结果。IMPACT-1 是一项随机、双盲、安慰剂对照的二期临床试验，评估TSND-201（甲基酮），一种速效神经塑化剂，用于治疗 PTSD。

This study enrolled 65 patients with severe PTSD (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5] ≥ 35), all of whom had previously tried a PTSD treatment, to receive 4 oral doses of TSND-201 or placebo, with each dose separated by one week. Patients were followed for a total of 64 days after the first dose..

本研究招募了65名严重 PTSD 患者（DSM-5临床医生管理的 PTSD 量表 [CAPS-5] ≥ 35），这些患者此前均尝试过 PTSD 治疗，随后接受4次口服 TSND-201 或安慰剂治疗，每次剂量间隔一周。患者在首次给药后总共被随访64天。

继续阅读

CAPS-5 Scores Over Time; * p <0.05

CAPS-5 分数随时间变化；* p <0.05

On the primary endpoint, change from baseline to Day 64, TSND-201 demonstrated a statistically significant placebo-adjusted CAPS-5 improvement of -9.64 points on Day 64 (-23.28 points vs. -13.64 points; p = 0.011). TSND-201 also demonstrated rapid and statistically significant improvements from baseline compared to placebo on the CAPS-5 total severity score.

在主要终点上，从基线到第64天的变化中，TSND-201在第64天显示出统计学显著的、经安慰剂调整的CAPS-5改善，降低了9.64分（-23.28分 vs. -13.64分；p = 0.011）。与安慰剂相比，TSND-201在CAPS-5总严重程度评分上也表现出快速且统计学显著的基线改善。

Starting on Day 10, TSND-201 demonstrated a statistically significant placebo-adjusted CAPS-5 improvement of -8.00 points (-17.83 points vs. -9.83 points; p = 0.012), which was durable throughout the study until Day 64..

从第10天开始，TSND-201显示出具有统计学意义的安慰剂校正CAPS-5改善，为-8.00点（-17.83点 vs. -9.83点；p = 0.012），这种改善在整个研究期间持续至第64天。

'We are encouraged by the positive Phase 2 results demonstrating TSND-201's potential as a rapid-acting and durable treatment for patients with PTSD,' said Transcend Therapeutics Co-Founder and CEO

“我们对2期试验结果感到鼓舞，这表明TSND-201作为一种快速起效且持久的PTSD患者治疗方案的潜力，”Transcend Therapeutics联合创始人兼首席执行官表示。

Blake Mandell

布莱克·曼德尔

. 'We look forward to working with the FDA to align on a Phase 3 program in PTSD.'

“我们期待与FDA合作，就PTSD的第三阶段计划达成一致。”

TSND-201 demonstrated statistically significant improvements on multiple secondary endpoints, including response (≥ 50% improvement from baseline on CAPS-5; 57.1% vs. 19.2%; p = 0.002), remission (≤ 11 points on the CAPS-5; 32.1% vs. 11.5%; p = 0.036), and loss of PTSD diagnosis (60.7% vs. 30.8%; p = 0.014)..

TSND-201在多个次要终点上表现出统计学上的显著改善，包括反应（在CAPS-5上较基线改善≥50%；57.1% vs. 19.2%；p = 0.002）、缓解（在CAPS-5上≤11分；32.1% vs. 11.5%；p = 0.036）以及PTSD诊断的消失（60.7% vs. 30.8%；p = 0.014）。

Treatment with TSND-201 was generally safe and well tolerated. The majority of adverse events were transient, occurring on the day of dosing and resolving the same day. The most commonly occurring adverse events in the TSND-201 group were headache, decreased appetite, nausea, dizziness, blood pressure increase, dry mouth, insomnia, muscle tightness, and feeling abnormal.

TSND-201治疗总体上是安全且耐受性良好的。大多数不良事件是短暂的，在给药当天发生并在同一天内消除。TSND-201组最常见的不良事件包括头痛、食欲减退、恶心、头晕、血压升高、口干、失眠、肌肉紧张和感觉异常。

One serious adverse event of seizure occurred in the TSND-201 group; the event occurred 7 days after the last dose in a patient with a history of seizure and was considered unrelated to study drug..

TSND-201组发生了一例严重的癫痫发作不良事件；该事件发生在一名有癫痫病史的患者中，距离最后一次给药后7天，被认为与研究药物无关。

'It has been over two decades without a new treatment for PTSD. The results of this study suggest that TSND-201 may represent a significant clinical breakthrough — demonstrating clinically meaningful efficacy with a rapid onset,' commented

“二十多年来一直没有新的 PTSD 治疗方法。这项研究的结果表明，TSND-201 可能代表了一个重大的临床突破——显示出具有快速起效的临床意义疗效，”评论道。

Murray B. Stein

穆雷·B·斯坦因

, M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the

医学博士、公共卫生硕士，精神病学与公共卫生杰出教授

University of California San Diego

加利福尼亚大学圣地亚哥分校

and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System. 'Rapid-acting, episodic treatments could be a paradigm shift in the treatment of PTSD, providing hope for the many patients who have struggled to find effective relief.'

圣地亚哥退伍军人事务医疗系统的精神科医生。'快速起效的、针对发作的治疗可能成为 PTSD 治疗的范式转变，为许多难以找到有效缓解方法的患者带来希望。'

About Transcend Therapeutics

关于Transcend Therapeutics

Transcend Therapeutics, founded in 2021, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Transcend's leadership team has made pivotal contributions to 14 FDA approvals and .

Transcend Therapeutics成立于2021年，是一家专注于神经科学的临床阶段公司，致力于开发快速起效的神经精神疾病治疗方法。该公司的使命是为数百万现有精神病药物无效的患者研发新药。Transcend的领导团队在14项FDA批准中做出了关键贡献。

$7B

70亿美元

in M&A and public company value. Transcend has raised approximately

在并购和上市公司价值方面。Transcend 已筹集了大约

$50M

5000万美元

to date.

迄今为止。

About TSND-201

关于TSND-201

TSND-201, a rapid-acting neuroplastogen, is a proprietary formulation of methylone developed by Transcend Therapeutics. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5HT-2a (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications.

TSND-201 是一种速效神经塑化剂，是 Transcend Therapeutics 开发的甲基酮专有配方。TSND-201 的主要药理特性已被充分研究，其主要作用部位位于单胺转运蛋白，并且在 5HT-2a 受体上无活性（即不具致幻性）。Transcend 正在开发 TSND-201 作为治疗 PTSD 和其他中枢神经系统 (CNS) 疾病的快速起效且持久的疗法。

TSND-201 is an investigational medication..

TSND-201是一种研究性药物。

About PTSD

关于 PTSD

PTSD is a mental health condition that can occur after experiencing or witnessing a life-threatening or traumatic event. Symptoms may include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event. PTSD impacts approximately 13 million Americans each year and it is estimated that nearly 7% of U.S.

创伤后应激障碍（PTSD）是一种心理健康状况，可能在经历或目睹危及生命或创伤性事件后发生。症状可能包括闪回、噩梦、严重焦虑以及对事件无法控制的想法。每年约有1300万美国人受到创伤后应激障碍的影响，据估计，近7%的美国人口在一生中某个时刻会受到影响。

adults will be diagnosed with PTSD during their lifetime. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), yet their efficacy is modest at best. New treatments for PTSD are urgently needed..

成年人在一生中会被诊断出患有 PTSD。只有两种药物被 FDA 批准用于治疗 PTSD（舍曲林和帕罗西汀），但它们的疗效充其量只是中等。迫切需要新的 PTSD 治疗方法。

Contact:

联系：

press@transcendtherapeutics.com

SOURCE Transcend Therapeutics

源超越治疗学

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