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

项目摘要/摘要 在美国，每年约有17,800人遭受急性脊髓损伤(SCI)。 虽然最近在脊髓损伤医疗管理方面的进展导致了诊断和治疗的改善 在这些患者稳定下来的情况下，目前在改善预后方面进展甚微 治疗方案。例如，只有不到1%的人在 出院时间和与脊髓损伤一起生活的终生成本平均可达510万美元 高位四肢瘫痪。VersaPeutics是一家正在开发新型单抗VersaMab-101的小企业 急性脊髓损伤的抗体治疗。传统上，脊髓损伤的生物疗法是通过鞘内给药的。 向脊髓内注入渗透泵。我们先前的研究已经证明了VersaMab-101的稳定性 FDA批准的可编程泵在模拟临床给药下。在本研究中，我们将 鼠鞘内注射VersaMab-101的药代动力学及药效研究 SCI的模型。在这个项目结束时，我们希望有高质量的数据集，这将为我们的临床 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。

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.