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

PROJECT SUMMARY/ABSTRACTEvery 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.