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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

基本信息

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
项目类别：
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

项目摘要

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/文摘