A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function

The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.
The main questions it aims to answer are:
Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?
Researchers will compare people with abnormal liver function to people with normal liver function.
Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.

开始日期2026-03-29

申办/合作机构

Lykos Therapeutics, Inc.初创企业

NCT04454684 / Not yet recruiting临床2期

An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders

This Phase 2, open-label, multi-site study will explore the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy and adjunctive caregiver involvement in the treatment of 18 participants with eating disorders. The study will enroll 12 participants with anorexia nervosa restricting-type (AN-R) and six participants with binge eating disorder (BED). A supportive caregiver, such as a parent or partner, for each participant will also be recruited to participate in the study and receive non-drug psychotherapy support. The study will consist of Preparatory Sessions, Experimental Sessions of MDMA-assisted psychotherapy, as well as Individual and Dyadic Integrative Sessions.
A flexible dose of MDMA will be given during Experimental Sessions, ranging from 80 to 120 mg with a supplemental half-dose of 40 or 60 mg 1.5 to 2 hours later, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results from Baseline to Visit 16 (Study Termination).

开始日期2026-02-01

申办/合作机构

Lykos Therapeutics, Inc.初创企业

NCT04073433 / Withdrawn临床1期

A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Psychotherapy When Administered to Healthy Volunteers

The purpose of this multi-site study is to collect information to support the safety profile of MDMA-assisted psychotherapy and to collect quantitative data on mood, psychological status, self-compassion, professional quality of life, and professional burnout in healthy volunteers after MDMA administration within a therapeutic setting. This exploratory study will permit an understanding of the acute effects of the drug in a specific and relevant setting for use in therapy.

开始日期2024-12-01

申办/合作机构

Lykos Therapeutics, Inc.初创企业

100 项与 Lykos Therapeutics, Inc. 相关的临床结果

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0 项与 Lykos Therapeutics, Inc. 相关的专利（医药）

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项与 Lykos Therapeutics, Inc. 相关的文献（医药）

2024-07-01·Journal of Humanistic Psychology

Psychedelics as a Training Experience for Psychedelic Therapists: Drawing on History to Inform Current Practice

作者: Nielson, Elizabeth M.

The therapeutic use of psilocybin in psychedelic-assisted therapy models is currently being tested for a variety of indications, necessitating the training of hundreds of therapists. At present, training programs do not include the provision of a psilocybin experience for therapists, and the last time such an experience was offered with a similar compound was through the Spring Grove LSD Training Study between 1969 and 1974. This article explores archival Spring Grove data to inform training programs and efforts to establish or provide training experiences with psilocybin or otherwise include experiences with nonordinary states of consciousness in the training of psychedelic therapists.

2024-07-01·Journal of Humanistic Psychology

MDMA-Assisted Therapy for Posttraumatic Stress Disorder: A Mixed-Methods Case Study of a Participant of Color From an Open-Label Trial

作者: Ching, Terence H. W. ; Emerson, Amy ; Wang, Julie B. ; Yazar-Klosinski, Berra ; Williams, Monnica T. ; Kisicki, Michael D. ; Doblin, Rick ; Reed, Sara J.

MDMA (±3,4-methylenedioxymethamphetamine)-assisted therapy (MDMA-AT) was shown in previous clinical trials to have promising efficacy and safety for alleviating treatment-resistant posttraumatic stress disorder (PTSD). However, due to low ethnoracial diversity, the question remains as to whether ethnoracial minority participants would benefit similarly. Thus, a mixed-methods case study was conducted on a participant of color from an open-label trial of MDMA-AT for PTSD to provide a culturally informed lens on symptom recovery with this treatment approach. An additional aim was to elucidate mechanisms of change underlying this treatment for the participant. A case profile was provided, documenting quantitative improvement in PTSD symptoms. This was followed by an interpretative phenomenological analysis (IPA) of effects and mechanisms of action for this participant, based on integration session transcripts. Results of IPA indicated recurrent themes related to psychological mechanisms of symptom change, reduced PTSD symptoms, and additional effects (positive and negative) beyond PTSD symptom reduction. These themes were discussed and recommendations for attuning to culturally relevant material during MDMA-AT were provided.

2023-01-01·Frontiers in psychiatry

Concomitant medications associated with ischemic, hypertensive, and arrhythmic events in MDMA users in FDA adverse event reporting system.

Article

作者: Dahill, Diane ; Jerome, Lisa ; Abagyan, Ruben ; de Boer, Alberdina ; Makunts, Tigran

3,4-Methylenedioxymethamphetamine (MDMA) is currently being investigated as an adjunctive treatment to therapy for posttraumatic stress and other anxiety related disorders in clinical trials. Within the next few years MDMA-assisted therapy is projected for approval by regulatory authorities. MDMA's primary mechanism of action includes modulation of monoamine signaling by increasing release and inhibiting reuptake of serotonin, norepinephrine, and, to a lesser extent, dopamine. This pharmacology affects sympathomimetic physiology. In controlled trials, special attention has been given to cardiovascular adverse events (AEs), because transient increases in heart rate and blood pressure have been observed during the MDMA-assisted therapy sessions. Finding and quantifying the potential drivers of cardiac AEs in clinical trials is difficult since only a relatively small number of participants have been included in these studies, and a limited set of allowed concomitant drugs has been studied. In this study a more diverse set of reports from the FDA Adverse Event Reporting System was surveyed. We found 17 cases of cardiovascular AEs, in which the individuals had taken one or more substances in addition to MDMA. Interestingly, all of those concomitant medications and illicit substances, including opioids, stimulants, anticholinergics, and amphetamines, had been previously associated with cardiovascular AEs. Furthermore, in none of the reports MDMA was marked as the primary suspect.

140

项与 Lykos Therapeutics, Inc. 相关的新闻（医药）

2024-10-21

·BioSpace

Lykos Announces ‘Productive’ Meeting With FDA Regarding Rejected MDMA Drug

FDA signage at its headquarters in Maryland iStock, hapabapa In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024. Nine weeks after the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, the company has taken its first steps forward, announcing a “productive” meeting with the agency. In a statement released Friday, the psychedelic drug developer said the meeting—led by new interim CEO Michael Mullette and new Chief Medical Officer David Hough—“resulted in a path forward” that will include an additional Phase III trial and a potential third-party review of prior Phase III data. The FDA in an Aug. 9 Complete Response Letter said Lykos’ application “could not be approved based on data submitted to date” and requested the company conduct an additional Phase III trial to glean more information on the safety and efficacy of MDMA. At that time, Lykos stated its intention to request a meeting with the regulator to “ask for reconsideration of the decision” and to seek FDA’s recommendations for a resubmission. Former CEO Amy Emerson said that an additional Phase III study “would take several years.” Emerson stepped down from her role in September after 10 years with the company. Along with naming Mullette as interim CEO, Lykos also introduced Hough as the company’s new CMO and said that he would spearhead the efforts to resubmit an FDA application for the MDMA therapy. Less than a week after the FDA rejection, Lykos announced it would lay off around 75% of its staff “with the remaining team focused on its ongoing clinical development, medical affairs, and engagement with the FDA.” On Friday, Lykos said it would “continue to work with the FDA on finalizing a plan” and continue to provide updates “as appropriate.”

临床3期高管变更

2024-10-18

·EndPoints

Lykos is optimistic about MDMA treatment after meeting with FDA

Lykos Therapeutics said it had a “productive” meeting with the FDA to discuss a path forward for its recently rejected PTSD treatment, in the first public statement from the company since a tumultuous period following the drug’s rejection. The company said the meeting between interim CEO Michael Mullette, Chief Medical Officer David Hough and the FDA “resulted in a path forward, including an additional Phase 3 trial, and a potential independent third-party review of prior Phase 3 clinical data.” The company said that it will work with the agency on finalizing a plan for its drug, midomafetamine, better known as the psychedelic MDMA. The FDA rejected the drug in August, setting off a chain of events including severe layoffs and executive changes . The brief readout of the meeting suggests Lykos isn’t likely to fight the FDA’s rejection of the drug. In September, Endpoints News reported that Lykos had planned to focus on fundraising to support an additional trial of the drug. It’s not clear what result could come from an independent review of the company’s prior trials. Those studies faced questions about their conduct from an advisory board that voted overwhelmingly against supporting the company’s application.

临床3期

2024-10-03

·药事纵横

FDA拒批5款药物|2024年7-9月

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。据不完全统计，2024年7-9月FDA共拒批了5款药物，小编总结如下： 01 再生元：linvoseltamab 8月20日，再生元宣布美国FDA已拒绝批准其BCMA/CD3双抗linvoseltamab用于治疗复发/难治性（R/R）多发性骨髓瘤（MM）的生物制品许可申请（BLA）。影响批准的问题与第三方公司灌装/包装制造有关。该第三方灌装/包装制造商已告知再生元公司这些问题已经解决，其工厂正在等待美国FDA在未来几个月内重进行新检查。Regeneron致力于与第三方灌装/成品制造商和FDA密切合作，尽快将linvoseltamab提供给合适的R/R MM患者，这一点至关重要，因为大多数MM患者都会复发，最终需要在晚期接受其他治疗。 Linvoseltamab是一款在研BCMA/CD3双特异性抗体，结合了再生元独有的全人源抗体技术VelocImmune和全长双抗技术平台VelociBi，与人体天然的抗体非常接近。该候选药物旨在将表达CD3的T细胞与多发性骨髓瘤细胞上的B细胞成熟抗原（BCMA）桥接，以促进T细胞活化和对癌细胞的杀伤。此次递交的BLA是基于一项关键性1/2期临床试验LINKER-MM1的结果。该临床试验（n=117）中接受剂量为200mg的linvoseltamab治疗的患者中观察到客观缓解率为71%，46%达到完全缓解或更佳。欧洲药品管理局（EMA）仍在对linvoseltamab同一适应症进行监管审查。Linvoseltamab尚处于研究阶段，其安全性和有效性尚未获得任何监管机构的批准。 02 Lykos：Midomafetamine 2024年8月9日，Lykos Therapeutics宣布美国FDA拒绝批准其用于治疗成人创伤后应激障碍（PTSD）的Midomafetamine（MDMA）胶囊的新药申请。FDA要求Lykos再进行额外的3期试验，以进一步研究Midomafetamine的安全性和有效性。Lykos计划要求与FDA会晤，请求重新考虑该决定，并进一步讨论该机构关于重新提交Midomafetamine胶囊申请监管批准的建议。 Lykos 此前已公布了其对咨询委员会听证会上讨论的实质性问题的回应。其中包括对Lykos临床数据不足以证明耐久性的担忧，以及对主要来自曾使用过Midomafetamine的参与者的预期偏差的质疑。Lykos认为，根据FDA的相关指南，NDA中包含的数据提供了充分的疗效和耐久性证据。 FDA的迷幻药行业指南草案指出，应在12周时收集终点数据；Lykos的3期研究在18周时收集终点数据，并在6个月或更长时间后收集额外的探索性终点数据。此外，Lykos 在2017年的特殊协议评估（SPA）中与FDA就研究设计中的各种偏倚最小化措施达成了一致。参与者曾使用过Midomafetamine并不被视为有害。例如，在Lykos的2期研究中，近30%的参与者报告曾使用过MDMA，而在3期试验设计中确定纳入和排除标准之前，已将这一情况告知FDA。咨询委员会的专家组成员还提出了心理干预的问题，一些专家建议进一步确定心理干预在多大程度上有助于提高治疗效果，以及是否有必要进行心理治疗。Lykos 承认MDMA辅助疗法是药物和疗法的新型组合，提出了独特的研究问题，并将继续与 FDA 就这些挑战保持适当的接触。Lykos 将继续致力于这一综合方法的开发。 03 Vanda：tradipitant 9月19日，Vanda Pharmaceuticals公司宣布，FDA拒绝批准其用于治疗胃轻瘫的药物tradipitant的新药上市申请（NDA），并提供了完全回复函（CRL）。 Tradipitant此次申请基于两项安慰剂对照试验的结果，且一项开放标签研究的数据以及真实世界的经验进一步支持了该药的疗效。尽管如此，CRL要求进行额外的研究，而Vanda公司认为这些要求与专家指导和对该疾病的当前理解不一致。该公司对FDA回应的延迟感到沮丧，因为这超过了法定的180天审查期限。 Vanda Pharmaceuticals现在对FDA的决定表示担忧，称tradipitant在治疗胃轻瘫方面已显示出足够的疗效和良好的利益风险比。该公司还请求FDA召开专家顾问委员会审查该药物，但这一请求已被拒绝。目前正在接受该药物治疗的患者已提交公民请愿，敦促FDA重新考虑其立场。 2023年12月4日，Vanda宣布tradipitant用于治疗胃轻瘫的新药申请（NDA）获FDA受理，PDUFA日期定为2024年9月18日。继1979年东莨菪碱获得FDA批准用于治疗晕动症后，FDA已经超40多年没有批准治疗晕动症的新药。Vanda当时称tradipitant一旦获批，将成为40多年来第一个被FDA批准用于治疗胃轻瘫的新药。 04 诺和诺德：Icodec 2024年7月10日，诺和诺德宣布每周一次胰岛素Icodec的上市申请收到FDA的完全回复函，FDA的要求主要是关于生产工艺和一型糖尿病适应症，诺和诺德与FDA密切沟通并达到这些要求，诺和诺德预计无法在 2024 年期间满足这些要求。诺和诺德于2023年4月向美国FDA提交了icodec胰岛素的申请。2024年5月，美国FDA内分泌与代谢药物咨询委员会召开会议，与会的独立科学专家小组讨论了每周一次的基础胰岛素 icodec在1型糖尿病中的效益-风险。专家小组认为，现有数据不足以对1型糖尿病的获益-风险做出肯定结论。咨询委员会没有讨论每周一次的胰岛素 icodec在2型糖尿病中的应用。胰岛素icodec在欧盟、加拿大、澳大利亚、日本和瑞士已被批准用于治疗1型和2 型糖尿病，在中国被批准用于治疗2型糖尿病，商标名为Awiqli®。 05 Orexo：OX124 2024年7月16日，Orexo宣布公司已收到美国FDA就OX124的新药上市申请 (NDA) 发出的完整答复函 (CRL)，OX124是一种针对阿片类药物过量而开发的高剂量纳洛酮抢救药物。该新药申请已于2023年9月18日提交给FDA。CRL表明需要进行额外的人为因素 (HF) 研究，这与之前的通报一致。此外，还要求提供有关最终商业产品的更多技术数据。CRL没有指出需要进行额外的临床或非临床研究。此次递交上市申请是基于一项在健康受试者中所进行关键研究（OX124-002）的数据。在该研究中，相比于肌肉注射的活性对照组，OX124中纳洛酮的吸收速度更快、程度更高。此外，在先前针对健康受试者的一项探索性临床试验（OX124-001）中，与市场上主要的纳洛酮救援药物相比，OX124的配方在相同剂量下显示出更快的吸收速度和更高的生物利用度。针对2024年4月收到的意见，Orexo已加紧努力优化使用说明。为满足FDA的要求，一项新的HF研究已顺利完成。FDA 要求提供额外的技术数据是意料之外的，Orexo现在将与FDA协商，迅速解决这一问题，以便尽快向FDA重新提交 NDA。重新提交NDA后的审查期将长达六个月。参考资料：各公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

临床3期加速审批

100 项与 Lykos Therapeutics, Inc. 相关的药物交易

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100 项与 Lykos Therapeutics, Inc. 相关的转化医学

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