STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy

美国FDA尚未批准任何治疗甲基苯丙胺(冰毒)使用障碍的药物。 目前，认知行为干预和应急管理干预是最有效的治疗方法。 IXT-M200是一种与血液中的冰毒特异结合的单抗，正在作为一种 与行为疗法结合使用的药物疗法。基于非临床研究， IXT-M200有望改变受试者的冰毒药代动力学，导致药物减少或受阻 强化冰毒使用的冰毒主观效应。STAMPOUT，2a期流行性出血热抗体研究 冰毒门诊治疗将提供IXT-M200可以改变冰毒的概念证明 性情。在进行大规模疗效研究之前，这是必要的。这项申请提出了第一个临床应用 专门为冰毒使用障碍患者开发的生物药物在冰毒使用者中的研究。 这项应用的主要目的是证明冰毒抗体会改变冰毒在体内的药代动力学。 并减少使冰毒使用永久化的强化主观影响。在STAMPOUT研究期间， 使用冰毒的受试者将接受单剂量的IXT-M200，然后每周接受冰毒挑战。连环血 将对样本和尿液收集进行分析，以确定由于 抗体剂量。冰毒挑战后给出的药物效果问卷将量化IXT-M200的影响 关于冰毒的主观影响。这些数据将被用来确定最低血清浓度 减少冰毒强化主观影响所必需的IXT-M200。同样在这个项目期间，将会有 与FDA的互动和整个临床开发计划将通过规划一个阶段来推进 在希望戒除冰毒的更大群体中进行的2B/3临床研究。IXT-M200的稳定性试验 药物产品将在整个研究期间继续进行，并根据需要进行额外的制造工作，以 支持STAMPOUT研究。 一支经验丰富、跨学科的学术和行业团队将完成以下具体工作 目标：1)通过与FDA的互动和对未来的规划，推动IXT-M200的临床开发 研究，2)完全STAMPOUT，2a期甲基苯丙胺门诊治疗抗体研究， 以及3)执行支持IXT-M200临床研究所需的制造任务。 STAMPOUT是一个转折点。有了概念验证数据，就可以制定计划来研究 IXT-M200帮助冰毒使用者戒烟，并将这款改变游戏规则的药物推向市场和 有需要的病人。

The US FDA has not approved any medications for the treatment of methamphetamine (METH) use disorders. Currently, cognitive-behavioral and contingency-management interventions are the most effective treatments. IXT-m200, a monoclonal antibody that specifically binds METH in the blood, is being developed as a pharmacological treatment for use in conjunction with behavior therapies. Based on nonclinical studies, IXT-m200 is expected to alter METH pharmacokinetics in human subjects resulting in reduced or blocked METH subjective effects that reinforce METH use. STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, will provide proof-of-concept that IXT-m200 can alter METH disposition. This is needed before a large efficacy study can be done. This application proposes the first clinical study in METH users of a biological medication developed specifically for patients with METH use disorders. The primary goal of this application is to show that a METH antibody will alter the pharmacokinetics of METH in users and reduce the reinforcing subjective effects that perpetuate METH use. During the STAMPOUT study, METH-using subjects will receive single doses of IXT-m200 followed by weekly METH challenges. Serial blood samples and urine collections will be analyzed to determine the METH pharmacokinetic changes due to the antibody dose. Drug effects questionnaires given after METH challenges will quantify the impact of IXT-m200 on the subjective effects of METH. These data will be used to determine the minimum serum concentration of IXT-m200 necessary for reducing reinforcing subjective effects of METH. Also during this project, there will be interaction with the FDA and the overall clinical development plan will be advanced by planning for a Phase 2b/3 clinical study in larger groups of users who wish to quit using METH. Stability testing of the IXT-m200 drug product will continue throughout the study, along with additional manufacturing work as necessary to support the STAMPOUT study. A highly experienced, transdisciplinary academic and industry team will accomplish the following Specific Aims: 1) Advance the clinical development of IXT-m200 by interacting with FDA and planning for future studies, 2) Complete STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, and 3) Perform manufacturing tasks required to support a clinical study of IXT-m200. STAMPOUT is a turning point. With proof-of-concept data, plans can be made to study long-term efficacy of IXT-m200 in helping METH users quit and move this game changing medication toward the market and the patients who need it.