BEDFORD, Mass.--(BUSINESS WIRE)--Delix Therapeutics, a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders, today announced additional data from an ongoing Phase 1 trial evaluating DLX-001, a novel neuroplastogen, demonstrating evidence of brain activity in healthy volunteers without producing psychotomimetic, dissociative or hallucinogenic effects.

马萨诸塞州贝德福德市（商业新闻短讯）--Delix Therapeutics是一家临床阶段的神经科学公司，开发了针对精神病和神经系统疾病的新型神经可塑性促进疗法，今天宣布了正在进行的一期试验的额外数据，该试验评估了DLX-001（一种新型神经塑化剂），证明了健康志愿者大脑活动的证据，而不会产生拟精神病，解离或致幻剂作用。

The Company also announced preclinical data showing the effects of DLX-001 on antidepressant, structural, and functional plasticity assays. These data were presented at the 2024 Society of Biological Psychiatry (SOBP) Annual Meeting from May 9-11 in Austin, Texas and will also be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting from May 28–31 in Miami Beach, Florida..

该公司还宣布了临床前数据，显示DLX-001对抗抑郁药，结构和功能可塑性测定的影响。这些数据于5月9日至11日在德克萨斯州奥斯汀举行的2024年生物精神病学学会（SOBP）年会上发表，也将于5月28日至31日在佛罗里达州迈阿密海滩举行的2024年美国临床精神药理学学会（ASCP）年会上发表。。

“Building on interim results presented at ACNP in December, we are encouraged by DLX-001’s favorable safety and tolerability profile to date, as well as time- and dose-dependent effects observed on quantitative EEG,” said Aaron Koenig, MD, Chief Medical Officer of Delix Therapeutics. “These results, coupled with a continued lack of hallucinogenic, psychotomimetic, or dissociative effects as we approach the end of this first-in-human study, reinforce our belief that DLX-001 has the potential to address significant unmet needs for patients suffering from MDD and related disorders.”.

Delix Therapeutics首席医疗官Aaron Koenig医学博士说：“在12月ACNP会议上公布的中期结果的基础上，我们对DLX-001迄今为止良好的安全性和耐受性以及在定量脑电图上观察到的时间和剂量依赖性效应感到鼓舞。”。“这些结果，再加上我们即将结束这项首次人体研究时持续缺乏致幻剂，拟精神病或解离作用，强化了我们的信念，即DLX-001有可能解决患有MDD和相关疾病的患者的重大未满足需求。”。

DLX-001, A Novel Neuroplastogen, Produces Rapid Time- and Dose-Dependent Increases in Delta and Theta Power on Quantitative EEG (qEEG)

DLX-001是一种新型神经塑化剂，在定量脑电图（qEEG）上产生快速的时间和剂量依赖性增量和θ功率

Lead Author: Aaron Koenig, M.D.

主要作者：医学博士Aaron Koenig。

Session Date: Thursday, May 9

会议日期：5月9日星期四

Session Time: 5:30-7:30pm CT

会议时间：康涅狄格州下午5:30-7:30

A three-part Phase 1 study will enroll over 100 healthy volunteers at the Center for Human Drug Research (CHDR) in The Netherlands, with the primary objectives of assessing safety, pharmacokinetics (PK), and markers of brain activity. Part A is a randomized, double-blind, placebo-controlled single ascending dose (SAD) study of DLX-001.

一项由三部分组成的第一阶段研究将在荷兰人类药物研究中心（CHDR）招募100多名健康志愿者，主要目标是评估安全性，药代动力学（PK）和大脑活动标志物。A部分是DLX-001的随机，双盲，安慰剂对照单次递增剂量（SAD）研究。

Part B is an open-label crossover design study to investigate the effect of food on the PK of DLX-001. Part C is a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in which participants receive multiple oral doses of either DLX-001 or placebo over 7 days..

B部分是一项开放标签交叉设计研究，旨在研究食物对DLX-001 PK的影响。C部分是一项随机，双盲，安慰剂对照的多次递增剂量（MAD）研究，参与者在7天内接受多次口服剂量的DLX-001或安慰剂。。

Key Findings

主要调查结果

DLX-001 has demonstrated a favorable safety and tolerability profile to date, with no serious adverse events.

迄今为止，DLX-001已显示出良好的安全性和耐受性，没有严重的不良事件。

No psychotomimetic, hallucinatory, or dissociative effects have been observed, as reflected by no change over time on a robust battery of assessments.

没有观察到拟精神病，幻觉或解离效应，这反映在一系列强大的评估中没有随时间变化。

Time and dose-dependent changes measured by resting-state quantitative electroencephalography (qEEG), paired with consistently measurable concentrations of compound in the cerebrospinal fluid (CSF), support brain penetration and the presence of target engagement with DLX-001.

通过静息状态定量脑电图（qEEG）测量的时间和剂量依赖性变化，与脑脊液（CSF）中持续可测量的化合物浓度相结合，支持大脑穿透和目标与DLX-001的结合。

The qEEG pattern of DLX-001 in healthy volunteers is characterized by increases in slow wave (delta and theta) activity consistent with the pattern observed with ketamine and Electro-Convulsive Therapy (ECT).

健康志愿者DLX-001的qEEG模式的特征是慢波（δ和θ）活性增加，与氯胺酮和电惊厥疗法（ECT）观察到的模式一致。

The maximum tolerated dose for DLX-001 has not yet been reached, and the study remains in progress.

DLX-001的最大耐受剂量尚未达到，研究仍在进行中。

Along with these additional Phase 1 data, Delix presented preclinical data characterizing DLX-001’s neuroplastic and therapeutic effects, including comparative data marking the beneficial efficacy of DLX-001 against ketamine, psilocybin, DMT, and differentiating from these compounds due to a lack of hallucinogenic liability..

除了这些额外的第一阶段数据外，Delix还提供了表征DLX-001神经可塑性和治疗效果的临床前数据，包括比较数据，这些数据标记了DLX-001对氯胺酮，裸盖菇素，DMT的有益功效，以及由于缺乏致幻性而与这些化合物的区别。。

Preclinical Pharmacology of DLX-001, a Novel Non-Hallucinogenic Neuroplastogen With the Potential for Treating Neuropsychiatric Diseases

DLX-001的临床前药理学，一种具有治疗神经精神疾病潜力的新型非致幻剂神经塑化剂

Lead Author: Kurt Rasmussen, Ph.D.

主要作者：Kurt Rasmussen博士。

Session Date: Saturday, May 11

会议日期：5月11日星期六

Session Time: 12:30–2:30pm CT

会议时间：康涅狄格州下午12:30–2:30

DLX-001 was examined in a series of in vitro, ex vivo, and in vivo assays relevant to neuroplasticity and major depressive disorder (MDD).

DLX-001在一系列与神经可塑性和重度抑郁症（MDD）相关的体外，离体和体内测定中进行了检查。

Key Findings

主要调查结果

In PK studies, DLX-001 was shown to be orally bioavailable and brain penetrant.

在PK研究中，DLX-001被证明是口服生物利用度和脑渗透剂。

In vitro studies demonstrate robust increases in neurite length and branching, increasing neuronal complexity.

体外研究表明，神经突长度和分支强烈增加，增加了神经元的复杂性。

Ex vivo, DLX-001 demonstrated robust effects on both structural and functional neuroplasticity after a single dose. The magnitude of these effects was on par with first generation compounds including ketamine, psilocybin, and DMT and were seen at doses relevant to the behavioral effects of each of these compounds..

离体，DLX-001在单剂量后对结构和功能性神经可塑性均表现出强大的作用。这些影响的程度与第一代化合物（包括氯胺酮，psilocybin和DMT）相当，并且在与每种化合物的行为影响相关的剂量下观察到。。

DLX-001 exhibited both rapid—within 24-hours, and enduring—up to 14 days, antidepressant-like activity after a single dose in multiple behavioral models.

DLX-001在多种行为模型中单次给药后，在24小时内表现出快速且持续长达14天的抗抑郁样活性。

In studies relevant to cardiotoxicity and hallucinations, no signal was identified for DLX-001.

在与心脏毒性和幻觉相关的研究中，没有发现DLX-001的信号。

About DLX-001

关于DLX-001

DLX-001 is a novel, non-hallucinogenic, and non-dissociative isotryptamine neuroplastogen currently undergoing initial human testing to treat those diagnosed with major depressive disorder (MDD) and other associated neuropsychiatric conditions. Preclinical data show that in efficacious doses, DLX-001 increased dendritic spine density in rat brain PFC layer-V pyramidal neurons and had rapid and enduring antidepressant-like effects after a single dose.

DLX-001是一种新型，非致幻剂和非解离性异ryptamine神经塑化剂，目前正在进行初步人体测试，以治疗被诊断患有重度抑郁症（MDD）和其他相关神经精神疾病的患者。临床前数据显示，在有效剂量下，DLX-001增加了大鼠脑PFC V层锥体神经元中的树突棘密度，并且在单剂量后具有快速且持久的抗抑郁样作用。

Recent phase 1 data found DLX-001 to be well tolerated, with no serious adverse events reported and robust signs of target engagement. In addition, researchers did not observe significant abnormalities among crucial safety indicators, including vital signs, electrocardiogram (ECG) readings, and laboratory analysis..

最近的第一阶段数据发现DLX-001耐受性良好，没有报告严重不良事件，目标参与的迹象强劲。此外，研究人员没有观察到关键安全指标的显着异常，包括生命体征，心电图（ECG）读数和实验室分析。。

About Neuroplastogens

关于神经母细胞原

Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of therapeutic areas including mood, anxiety, cognitive, and neurodegenerative disorders in addition to other synaptopathies.

神经塑化剂是一类针对精神和神经疾病的新型潜在疾病改善疗法。这些化合物在选择的神经回路中促进快速和持续的神经可塑性，从而产生快速的治疗效果。神经塑化剂是受化合物启发的新型化学实体，这些化合物被证明在包括情绪，焦虑，认知和神经退行性疾病以及其他突触病在内的一系列治疗领域都是有益的。

Leveraging our phenotypic drug discovery engine to generate distinct compounds, Delix seeks to bring to market a pipeline of neuroplastogens that will be the faster, stronger, and more effective therapies of the future..

Delix利用我们的表型药物发现引擎产生不同的化合物，试图将神经塑化剂管道推向市场，这将是未来更快，更强，更有效的疗法。。

About Delix Therapeutics

关于Delix Therapeutics

Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company's compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain.

Delix Therapeutics是一家临床阶段的神经科学公司，专注于利用新型神经可塑性促进疗法的力量，更好地治疗患有难以治疗的神经精神和神经疾病的患者。该公司的化合物是易于制造的小分子，能够快速诱导大脑目标区域的结构和功能神经变化。

Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that will serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers..

通过其新型神经塑化剂平台，Delix开创了一类新的速效门诊药物疗法，并通过临床前和临床开发迅速发展，为患者提供FDA批准的带回家的药物，这些药物将满足一些未满足的需求，并增强患者和提供者的精神病治疗范式。。