EMP-01 (R-MDMA) was generally well-tolerated and treatment-related adverse events (AEs) were as expectedThe PK profile of EMP-01 was dose-proportional, and a range of exploratory pharmacodynamic (PD) measures, including subjective reports and blood-based biomarkers, showed dose-dependent changes EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA, a result that is likely to have therapeutic implications NEW YORK and BERLIN, Jan.

EMP-01（R-MDMA）通常耐受性良好，治疗相关不良事件（AE）如预期的那样。EMP-01的PK曲线与剂量成正比，一系列探索性药效学（PD）测量，包括主观报告和基于血液的生物标志物，显示出剂量依赖性变化。与外消旋MDMA相比，EMP-01给药导致了不同的主观体验，这一结果可能具有治疗意义，纽约和柏林，1月。

02, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA (3,4-methylenedioxy-methamphetamine).

2024年2月2日（环球通讯社）--atai生命科学公司（纳斯达克：atai）（“atai”）是一家临床阶段的生物制药公司，旨在改变精神健康障碍的治疗方法，该公司宣布了其评估口服EMP-01（MDMA（3,4-亚甲二氧基甲基苯丙胺）的R-对映体）的第一阶段研究的积极结果。

The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01. The four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled study enrolled 32 healthy participants who received 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design.

这项第一阶段研究的目标是评估EMP-01的安全性，耐受性，药代动力学（PK）和药效学（PD）。这项四队列，单次递增剂量，随机，双盲，安慰剂对照研究招募了32名健康参与者，他们在6+2设计中接受75mg，125mg，175mg或225mg EMP-01或安慰剂。

EMP-01 was well-tolerated, and treatment-related adverse events (AEs) were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe AEs were observed in the study. Non-clinically significant increases in blood pressure and heart rate were observed, though such changes showed limited dose dependency.

EMP-01耐受性良好，治疗相关不良事件（AE）均在预期范围内，通常呈剂量依赖性。没有研究中断，研究中没有观察到严重或严重的AE。观察到血压和心率的非临床显着增加，尽管这种变化显示出有限的剂量依赖性。

Further, the peak body temperatures observed fell within the normal range. Finally, bruxism was observed in only 1 of 24 subjects that received EMP-01. The PK profile of EMP-01 was dose-proportional. The PD measures included both subjective reports and blood-based biomarkers. Significant, consistent .

此外，观察到的峰值体温落在正常范围内。最后，在接受EMP-01的24名受试者中，只有1名观察到磨牙症。EMP-01的PK曲线与剂量成正比。PD测量包括主观报告和基于血液的生物标志物。重要、一致。