Optimization and testing of anti-methamphetamine antibody therapy to support pivotal clinical trials and commercialization
抗甲基苯丙胺抗体疗法的优化和测试以支持关键的临床试验和商业化
基本信息
- 批准号:10152573
- 负责人:
- 金额:$ 316.57万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-05-01 至 2023-02-28
- 项目状态:已结题
- 来源:
- 关键词:Active SitesAdvanced DevelopmentAdverse eventAffinityAnnual ReportsAntibodiesAntibody TherapyBehavioralBindingBiological AvailabilityBioreactorsBloodBrainCardiovascular systemCell LineCellsClinicClinicalClinical ProtocolsClinical ResearchClinical TrialsCounselingDataDevelopmentDiseaseDoseDrug KineticsDrug abuseExcipientsFormulationGoalsGrowthHalf-LifeHepaticHumanImmune responseInfusion proceduresKidneyMedicalMedicineMethamphetamineMethamphetamine dependenceMonoclonal AntibodiesOutcomeOutpatientsPathway interactionsPatientsPenetrationPharmaceutical PreparationsPhasePilot ProjectsPreparationProcessProductionProductivityProfessional counselorProgram DevelopmentProtocols documentationPublic HealthRattusRegimenRegulationReportingRouteRunningSafetySerious Adverse EventSpecific qualifier valueSubcutaneous InjectionsTestingTherapeuticTherapeutic antibodiesTherapy trialTimeToxicologyUpdateWorkcell bankcommercializationdesigndrug standardhealthy volunteerimmunogenicityimprovedinnovationmanufacturing processmedication compliancemeetingsmethamphetamine abusemethamphetamine effectmethamphetamine usemethamphetamine userminiaturizephase 1 studyphase 2 studypreclinical studysubcutaneoustreatment programvolunteer
项目摘要
InterveXion is developing an anti-methamphetamine (METH) monoclonal antibody called IXT-m200 for the
treatment of METH use disorders. Single doses of IXT-m200 have been well-tolerated in healthy volunteers
and also METH users who are given weekly doses of METH (30 mg, IV) following IXT-m200 administration.
Importantly, an interim analysis of our ongoing Phase 2 study shows that IXT-m200 alters METH distribution in
humans as predicted from nonclinical data, specifically by greatly reducing METH volume of distribution, i.e.,
sequestering METH in the blood. No serious adverse events or adverse event greater than mild or moderate
have been reported in the Phase 2 study.
The currently proposed long-term nonclinical studies will facilitate multiple dose clinical trials to test IXT-m200
for efficacy in reducing METH use. In addition, InterveXion will improve the manufacturing process for IXT-
m200 and thereby comply with new regulations that have been imposed since the IXT-m200 development
program began. Finally, subcutaneous administration of IXT-m200 will be explored as a potential improvement
to the dosing regimen. Subcutaneous injections may be given in an office or counseling setting, would allow
patients to more easily receive IXT-m200, and should improve medication compliance.
The major goal of this proposal is to move IXT-m200 to the next milestone in the FDA approval process, which
is multiple dose studies in humans, such as pivotal Phase 2b/3 studies. The specific aims that will allow this
goal to be met are as follows. Aim 1: Manufacture IXT-m200 to support required nonclinical and clinical
studies. A single cell will be isolated and used to generate a new Master Cell Bank with improved production
capabilities. Two batches will be made to provide material for Aim 2 and upcoming clinical trials. Aim 2:
Complete multiple dose studies of IXT-m200 in rats to support multiple dose administration in humans. A
6-month toxicology study with 27 weekly doses of IXT-m200 in rats will be done following the successful
completion of a pilot study. Aim 3: Conduct studies to determine the feasibility of subcutaneous administration
of IXT-m200. IXT-m200 will be concentrated to at least 140 mg/mL and given to rats by subcutaneous
injection. Antibody pharmacokinetics, METH binding capability and immunogenicity will be tested. Aim 4:
Prepare for first multiple dose clinical study by communicating with FDA, maintaining the IND, and developing
a full clinical protocol. All regulatory interactions and requirements will be completed under this aim so that a
multiple dose clinical trial may begin as soon as this work is completed.
The treatment of METH use disorder remains an unmet medical need with no medications yet approved by the
US FDA. InterveXion continues to strive to meet this need by pushing forward quickly with the development of
the first METH-binding mAb, IXT-m200. These studies are the next steps toward meeting that need.
InterveXion 正在开发一种名为 IXT-m200 的抗甲基苯丙胺 (METH) 单克隆抗体,用于
治疗冰毒使用障碍。单剂量 IXT-m200 在健康志愿者中具有良好的耐受性
以及在 IXT-m200 给药后每周给予 METH 剂量(30 毫克,静脉注射)的 METH 使用者。
重要的是,我们正在进行的 2 期研究的中期分析表明,IXT-m200 改变了 METH 的分布
根据非临床数据预测,人类,特别是通过大大减少 METH 的分布量,即
将冰毒隔离在血液中。无严重不良事件或大于轻度或中度的不良事件
已在第二阶段研究中报告。
目前提出的长期非临床研究将促进多剂量临床试验来测试IXT-m200
减少冰毒使用的功效。此外,InterveXion将改进IXT-的制造工艺
m200,从而符合自 IXT-m200 开发以来实施的新法规
节目开始了。最后,将探索 IXT-m200 的皮下给药作为潜在的改进
到给药方案。皮下注射可以在办公室或咨询机构进行,这样可以
患者为了更容易接受IXT-m200,并应提高用药依从性。
该提案的主要目标是将 IXT-m200 推向 FDA 审批流程的下一个里程碑,这
是针对人体的多剂量研究,例如关键的 2b/3 期研究。实现这一目标的具体目标
要达到的目标如下。目标 1:制造 IXT-m200 以支持所需的非临床和临床
研究。将分离单个细胞并用于生成产量提高的新主细胞库
能力。将生产两批,为目标 2 和即将进行的临床试验提供材料。目标 2:
在大鼠中完成 IXT-m200 的多剂量研究,以支持人类的多剂量给药。一个
成功后,将在大鼠中进行为期 6 个月的毒理学研究,每周 27 剂 IXT-m200
完成试点研究。目标 3:进行研究以确定皮下给药的可行性
IXT-m200。 IXT-m200将浓缩至至少140 mg/mL并通过皮下注射给大鼠
注射。将测试抗体药代动力学、METH 结合能力和免疫原性。目标 4:
通过与 FDA 沟通、维护 IND 并开发药物,为首次多剂量临床研究做好准备
完整的临床方案。所有监管互动和要求都将在此目标下完成,以便
这项工作完成后即可开始多剂量临床试验。
冰毒使用障碍的治疗仍然是一个未满足的医疗需求,目前尚未批准任何药物
美国FDA。 InterveXion 继续努力通过快速推进技术的发展来满足这一需求
第一个 METH 结合单克隆抗体 IXT-m200。这些研究是满足这一需求的下一步。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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W BROOKS GENTRY其他文献
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{{ truncateString('W BROOKS GENTRY', 18)}}的其他基金
OUTLAST - A First Multiple-Dose Efficacy Study of IXT-m200, an anti-METH Monoclonal Antibody, in Patients with METH Use Disorder
OUTLAST - IXT-m200(一种抗冰毒单克隆抗体)在冰毒使用障碍患者中的首次多剂量疗效研究
- 批准号:
10399794 - 财政年份:2021
- 资助金额:
$ 316.57万 - 项目类别:
OUTLAST - A First Multiple-Dose Efficacy Study of IXT-m200, an anti-METH Monoclonal Antibody, in Patients with METH Use Disorder
OUTLAST - IXT-m200(一种抗冰毒单克隆抗体)在冰毒使用障碍患者中的首次多剂量疗效研究
- 批准号:
10686245 - 财政年份:2021
- 资助金额:
$ 316.57万 - 项目类别:
Meth-OD: A PHASE 2A STUDY OF IXT-M200 IN METHAMPHETAMINE OVERDOSE PATIENTS
Meth-OD:IXT-M200 在甲基苯丙胺过量患者中的 2A 期研究
- 批准号:
10269933 - 财政年份:2020
- 资助金额:
$ 316.57万 - 项目类别:
Meth-OD: A PHASE 2A STUDY OF IXT-M200 IN METHAMPHETAMINE OVERDOSE PATIENTS
Meth-OD:IXT-M200 在甲基苯丙胺过量患者中的 2A 期研究
- 批准号:
10425428 - 财政年份:2020
- 资助金额:
$ 316.57万 - 项目类别:
STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy
STAMPOUT:甲基苯丙胺门诊治疗抗体的 2a 期研究
- 批准号:
9458985 - 财政年份:2017
- 资助金额:
$ 316.57万 - 项目类别:
STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy
STAMPOUT:甲基苯丙胺门诊治疗抗体的 2a 期研究
- 批准号:
9762072 - 财政年份:2017
- 资助金额:
$ 316.57万 - 项目类别:
Transition to Human Phase 1b Trials: Nonclinical Studies of an Anti-METH mAb
过渡到人体 1b 期试验:抗 METH 单克隆抗体的非临床研究
- 批准号:
9398663 - 财政年份:2017
- 资助金额:
$ 316.57万 - 项目类别:
Transition to Human Phase 1b Trials: Nonclinical Studies of an Anti-METH mAb
过渡到人体 1b 期试验:抗 METH 单克隆抗体的非临床研究
- 批准号:
9115554 - 财政年份:2014
- 资助金额:
$ 316.57万 - 项目类别:
Transition to Human Phase 1b Trials: Nonclinical Studies of an Anti-METH mAb
过渡到人体 1b 期试验:抗 METH 单克隆抗体的非临床研究
- 批准号:
8926379 - 财政年份:2014
- 资助金额:
$ 316.57万 - 项目类别:
Transition to Human Phase 1b Trials: Nonclinical Studies of an Anti-METH mAb
过渡到人体 1b 期试验:抗 METH 单克隆抗体的非临床研究
- 批准号:
8827127 - 财政年份:2014
- 资助金额:
$ 316.57万 - 项目类别:
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