Pharmacokinetics and efficacy of intrathecal VersaMab-101 delivery foracute spinal cord injury

鞘内 VersaMab-101 递送治疗急性脊髓损伤的药代动力学和疗效

• 批准号: 10484664
• 负责人: Miao Sun
• 金额: $ 49.51万
• 依托单位: VERSAPEUTICS INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484664
• 关键词: Acute; Adult; Agreement; Animal Model; Antibodies; Antibody Therapy; Axon; Behavior; Biodistribution; Biological Assay; Biological Response Modifier Therapy; Blood; Blood - brain barrier anatomy; Bolus Infusion; Brain; Businesses; California; Chest; Clinic; Clinical; Clinical Treatment; Clinical Trials; Communities; Community Developments; Continuous Infusion; Contusions; Cues; Data; Data Set; Development; Development Plans; Devices; Diagnosis; Dose; Drug Kinetics; Embryo; Engineering; Enzyme-Linked Immunosorbent Assay; FDA approved; Formulation; Funding; Future; Goals; Heart; Histologic; Hospitals; Human; Immunohistochemistry; In Vitro; Individual; Infusion procedures; Injury; Kidney; Laboratories; Legal patent; Lesion; Licensing; Liquid substance; Liver; Living Costs; Locomotion; Lung; Measures; Mechanics; Medical; Modeling; Molecular; Monoclonal Antibodies; Monoclonal Antibody Therapy; Mus; National Institute of Neurological Disorders and Stroke; Neuraxis; Outcome; Patients; Permeability; Persons; Pharmaceutical Preparations; Proteins; Publishing; Pump; Quadriplegia; Rattus; Recovery; Recovery of Function; Regimen; Rodent Model; Safety; Sampling; Series; Serum; Site; Small Business Innovation Research Grant; Solid; Spinal Cord; Spinal cord injury; Spinal cord injury patients; System; Testing; Time; Tissues; Toxic effect; United States; Universities; Walking; Work; allodynia; axon guidance; axon injury; base; chronic pain; clinical development; drug development; experience; functional improvement; humanized antibody; immunogenicity; improved; improved outcome; in vivo; lead candidate; life time cost; motor control; neurological recovery; novel; novel therapeutics; potency testing; professor; programs; receptor; regenerative growth

PROJECT SUMMARY/ABSTRACT Every year in the United States, approximately 17,800 people suffer acute spinal cord injuries (SCI). While recent advances in the medical management of SCI have led to improvements in the diagnosis and stabilization of these patients, there has been minimal progress made towards improving outcomes with current treatment options. For instance, fewer than 1% of individuals experience complete neurological recovery by the time of hospital discharge, and the lifetime costs of living with an SCI can average up to $5.1M for individuals with high tetraplegia. VersaPeutics is a small business that is developing VersaMab-101, a novel monoclonal antibody therapy for acute SCI. Traditionally, biologic therapeutics for SCI have been delivered intrathecally via osmatic pump into the spinal cord. Our previously study has demonstrated the stability of VersaMab-101 in one of the FDA approved programmable pump under a simulated clinic administration. In the present study, we will examine the pharmacokinetics and efficacy of intrathecally administration of VersaMab-101 by using rodent models of SCI. At the end of this project, we expect to have high quality datasets that will inform our clinical development plans for VersaMab-101 and also will be published to help the spinal cord injury drug development community.

项目总结/摘要 在美国，每年约有17，800人遭受急性脊髓损伤（SCI）。 虽然SCI的医疗管理的最新进展已经导致了诊断和治疗的改善， 这些患者的稳定，在改善目前的结局方面取得的进展甚微。 治疗方案。例如，不到1%的人在治疗前经历了完全的神经恢复。 出院时间，以及SCI患者的终身生活成本平均可高达510万美元 四肢高度瘫痪VersaPeutics是一家正在开发VersaMab-101的小企业， 急性SCI的抗体治疗。传统上，SCI的生物治疗剂已经通过鞘内给药， 渗透泵进入脊髓我们之前的研究已经证明了VersaMab-101在一个 FDA批准的可编程泵在模拟临床管理下的性能。在本研究中，我们将 使用啮齿动物检查VersaMab-101鞘内给药的药代动力学和疗效 SCI模型在这个项目结束时，我们希望有高质量的数据集，将告知我们的临床 VersaMab-101的开发计划也将公布，以帮助脊髓损伤药物的开发 社区