BEDFORD, Mass.--(BUSINESS WIRE)--Delix Therapeutics, a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders, today announced interim results from the Phase 1 trial evaluating DLX-001, a novel neuroplastogen, in healthy volunteers, which were presented at the 2023 American College of Neuropsychopharmacology (ACNP) Annual Meeting in Tampa, Florida.

马萨诸塞州贝德福德（商业新闻短讯）--Delix Therapeutics是一家临床阶段的神经科学公司，开发了针对精神和神经疾病的新型神经可塑性促进疗法，今天宣布了在健康志愿者中评估新型神经塑性原DLX-001的第一阶段试验的中期结果，这是在佛罗里达州坦帕市举行的2023年美国神经心理药理学学院（ACNP）年会上提出的。

Preclinical data characterizing the compound were also presented at the meeting..

会议上还介绍了表征该化合物的临床前数据。。

“While ketamine and serotonergic psychedelics have shown promise for treating certain neuropsychiatric disorders, they are also associated with troublesome side effects and cardiac risks,” said Aaron Koenig, MD, Chief Medical Officer of Delix Therapeutics. “We are encouraged by our preliminary Phase 1 results, which indicate that DLX-001 is safe, well-tolerated, and, as predicted by our preclinical studies, does not produce hallucinogenic, psychotomimetic, or dissociative effects in healthy volunteers.

Delix Therapeutics首席医疗官Aaron Koenig医学博士说：“虽然氯胺酮和5-羟色胺能迷幻剂有望治疗某些神经精神疾病，但它们也会带来麻烦的副作用和心脏风险。”。“我们对第一阶段的初步结果感到鼓舞，这表明DLX-001是安全的，耐受性良好，并且正如我们的临床前研究所预测的那样，不会对健康志愿者产生致幻剂，拟精神病或解离作用。

Importantly, preclinical findings confirm DLX-001’s ability to robustly promote structural and functional neuroplasticity in vivo in the prefrontal cortex, which we believe drives the underlying efficacy of this class of fast-acting agents. We look forward to the continued development of DLX-001, as we believe it has the potential to address the significant unmet medical needs of patients suffering from difficult-to-treat neuropsychiatric conditions.”.

重要的是，临床前研究结果证实DLX-001能够强有力地促进前额叶皮层体内的结构和功能性神经可塑性，我们认为这是这类速效药物潜在功效的驱动因素。我们期待DLX-001的持续发展，因为我们相信它有可能解决患有难以治疗的神经精神疾病的患者的重大未满足的医疗需求。”。

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of DLX-001, a Novel Neuroplastogen

一项I期研究，用于评估新型神经塑化剂DLX-001的安全性，耐受性和药代动力学特征

Lead Author: Aaron Koenig, M.D.

主要作者：医学博士Aaron Koenig。

Session Date: Monday, December 4

会议日期：12月4日星期一

Session Time: 5:00pm-7:00pm EST

会议时间：东部标准时间下午5:00-7:00

The Phase 1, three-part study is enrolling approximately 100 healthy volunteers 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. Part B is a standard, open-label, crossover design study to investigate the effect of food on the PK of DLX-001.

第一阶段的三部分研究招募了大约100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。B部分是一项标准的，开放标签的交叉设计研究，旨在研究食物对DLX-001 PK的影响。

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..

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

In the 62 healthy volunteers dosed so far, DLX-001 demonstrated a favorable safety profile and was well-tolerated, with no serious adverse events reported to-date.

在迄今为止服用的62名健康志愿者中，DLX-001表现出良好的安全性，耐受性良好，迄今为止尚未报告严重不良事件。

No psychotomimetic, hallucinatory, or dissociative effects were observed, as reflected by no change over time on a robust battery of metrics including the Clinician-Administered Dissociative States Scale (CADSS), Bond & Lader Visual Analogue Scale (B&L VAS), Bowdle Visual Analogue Scale (Bowdle VAS), and Mystical Experience Questionnaire 30 (MEQ-30)..

没有观察到精神模拟，幻觉或解离效应，这反映在一系列强大的指标上没有随时间变化，包括临床医生管理的解离状态量表（CADSS），Bond＆Lader视觉模拟量表（B＆L VAS），Bowdle视觉模拟量表（Bowdle VAS）和神秘体验问卷30（MEQ-30）。。

DLX-001 is orally bioavailable, achieves plasma exposures within the predicted therapeutic range, and achieves measurable levels within the CSF.

DLX-001是口服生物可利用的，在预测的治疗范围内达到血浆暴露，并在CSF内达到可测量的水平。

The maximum tolerated dose for DLX-001 has not yet been reached; additional cohorts are in progress.

DLX-001的最大耐受剂量尚未达到；其他队列正在进行中。

In addition to these interim clinical 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, and DMT and differentiating it from these compounds on hallucinogenic liability..

除了这些临时临床数据外，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，裸盖菇素和DMT的有益功效，并将其与这些化合物在致幻责任上进行了区分。。

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: Tuesday, December 5

会议日期：12月5日星期二

Session Time: 5:00pm-7:00pm EST

会议时间：东部标准时间下午5:00-7:00

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

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

Key Findings

主要调查结果

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

在药代动力学（PK）研究中，DLX-001被证明是口服生物利用度和脑渗透剂。

In a phenotypic screen of neurite outgrowth in neuronal cell cultures, DLX-001 produced significant increases in both neurite length and complexity.

在神经元细胞培养物中神经突生长的表型筛选中，DLX-001产生了神经突长度和复杂性的显着增加。

In vivo, DLX-001 demonstrated significant effects on promoting both structural and functional neuroplasticity on par with the 1st generation compounds ketamine and psilocybin after a single dose

在体内，DLX-001在单剂量后与第一代化合物氯胺酮和裸盖菇素相比，在促进结构和功能神经可塑性方面表现出显着效果

DLX-001 exhibited both rapid, within 24-hours, and enduring, up to 7 days, antidepressant-like activity after a single dose in behavioral assays

DLX-001在行为测定中单次给药后，在24小时内表现出快速且持续长达7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。

Importantly, DLX-001 met or exceeded the efficacy and duration of effect of first-generation psychoplastogens, including DMT, psilocybin, and ketamine.

重要的是，DLX-001达到或超过了第一代精神塑化剂（包括DMT，psilocybin和氯胺酮）的功效和作用持续时间。

“Delix is excited to share these data from DLX-001, the first novel neuroplastogen to enter clinical testing. These data reinforce the potential of our broader neuroplastogen platform to develop therapies that can repair damaged neurons,” said Delix CEO Mark Rus. “We are particularly impressed with DLX-001’s ability to cross the blood-brain barrier and achieve therapeutic exposures, which is a common challenge in CNS drug development, but not produce hallucinogenic effects.”.

Delix首席执行官Mark Rus说：“Delix很高兴分享DLX-001的这些数据，DLX-001是第一个进入临床测试的新型神经塑化剂。这些数据增强了我们更广泛的神经塑化剂平台开发修复受损神经元的疗法的潜力。”。“我们对DLX-001跨越血脑屏障并实现治疗暴露的能力印象特别深刻，这是中枢神经系统药物开发中的常见挑战，但不会产生致幻剂作用。”。

Delix is also announcing today the appointment of Jeff Jonas, M.D., to the company's Strategic & Scientific Advisory Board. Dr. Jonas brings decades of experience in R&D leadership and cutting-edge CNS drug discovery and development across brands that have successfully helped millions of patients, such as Lexapro, Vyvanse, Zulresso, Zurzuvae and Namenda.

Delix今天还宣布任命医学博士杰夫·乔纳斯为公司战略与科学顾问委员会成员。Jonas博士在研发领导和尖端中枢神经系统药物发现和开发方面拥有数十年的经验，这些品牌已成功帮助了数百万患者，如Lexapro，Vyvanse，Zulresso，Zurzuvae和Namenda。

In addition, across roles such as CEO of Sage Therapeutics, and Board Member of Karuna Therapeutics, Jeff's significant company building and advisory experience has generated considerable shareholder and stakeholder value, particularly when developing novel scientific approaches to CNS..

此外，在Sage Therapeutics首席执行官和Karuna Therapeutics董事会成员等职位上，杰夫的重要公司建设和咨询经验为股东和利益相关者带来了可观的价值，特别是在开发新的中枢神经系统科学方法时。。

'The Delix team and I are thrilled that Jeff has joined us as a Scientific and Strategic Advisor,' said Delix CEO Mark Rus. 'Jeff's proven track record and experience will be invaluable to Delix in the future. He and his teams have significantly advanced the CNS treatment landscape throughout his career.

Delix首席执行官马克·罗斯（MarkRus）说：“Delix团队和我都很高兴杰夫成为我们的科学和战略顾问。”杰夫久经考验的业绩和经验对德里克斯未来将是无价的。在他的职业生涯中，他和他的团队极大地推动了中枢神经系统治疗领域的发展。

I look forward to leveraging his considerable experiences as we progress our novel neuroplastogen platform and build Delix into a leading neuroscience company.'.

我期待着利用他的丰富经验，推动我们新型神经塑化剂平台的发展，并将Delix打造成领先的神经科学公司。”。

'The therapies being developed by Delix and their overall approach to repairing neuronal atrophy have the potential to shift the treatment paradigm for several neuropsychiatric conditions,' said Dr. Jonas. 'I look forward to working with Delix's talented management and scientific team as they advance a pipeline of non-hallucinatory neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat disorders.”.

乔纳斯博士说：“德里克斯正在开发的疗法及其修复神经元萎缩的整体方法有可能改变几种神经精神疾病的治疗模式。”我期待着与Delix的天才管理和科学团队合作，推动非幻觉神经可塑性促进疗法的发展，以更好地治疗患有难治性疾病的患者。”。

About Jeffrey Jonas

关于杰弗里·乔纳斯

Jeffrey Jonas, M.D., has more than 25 years of experience in drug development and discovery across multiple therapeutic areas in the pharmaceutical and healthcare industries. Dr. Jonas has served as CEO and Chief Innovation Officer of Sage Therapeutics, where he led the development of industry-leading CNS treatments and development pipelines.

医学博士杰弗里·乔纳斯（JeffreyJonas）在制药和医疗保健行业的多个治疗领域拥有超过25年的药物开发和发现经验。Jonas博士曾担任Sage Therapeutics的首席执行官和首席创新官，负责开发行业领先的中枢神经系统治疗和开发管道。

Before Sage, he was President of the Regenerative Medicine Division at Shire Pharmaceuticals. Earlier on his career, Dr. Jonas served as Executive Vice President of ISIS Pharmaceuticals and held senior positions at Forest Laboratories, Inc. and Upjohn Laboratories. He received his M.D. from Harvard Medical School and a B.A.

在Sage之前，他是Shire Pharmaceuticals再生医学部门的总裁。在职业生涯早期，乔纳斯博士曾担任ISIS制药公司的执行副总裁，并在Forest Laboratories，Inc.和Upjohn Laboratories担任高级职位。他获得了哈佛医学院的医学博士学位和学士学位。

from Amherst College..

来自阿默斯特学院。。

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 suggests that in efficacious doses, DLX-001 increased dendritic spine density in rat brain layer-V PFC 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。临床前数据表明，在有效剂量下，DLX-001增加了大鼠脑V层PFC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 safe and well tolerated, with no serious adverse events reported. 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安全且耐受性良好，未报告严重不良事件。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。

Generated from our phenotypic drug discovery engine, Delix’s seeks to bring to market a pipeline of neuroplastogens that will be the faster, stronger, and more effective therapies of the future..

Delix从我们的表型药物发现引擎中产生，旨在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。。