A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

NVG‐291 is an investigational peptide therapeutic designed to promote nervous systemrepair by modulating pathways that may inhibit neural regeneration after spinal cordinjury. Chronic cervical motor‐incomplete spinal cord injury is associated withpersistent impairments in upper‐extremity function, mobility, independence, and qualityof life, and there are currently no approved pharmacologic therapies specificallyintended to promote neurological repair in this population. Previous nonclinical studiesand an earlier randomized clinical study of NVG‐291 provided evidence supporting furtherevaluation of its potential to improve neurological connectivity and functional recoveryin individuals with chronic cervical motor incomplete spinal cord injury.RESTORE (NVG‐291‐301) is a Phase 3, randomized, double‐blind, placebo‐controlled,multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics ofNVG‐291 in adults with chronic cervical motor incomplete spinal cord injury.Approximately 150 participants will be enrolled at up to 60 sites in the United Statesand Canada and randomized in a 1:1 ratio to receive either NVG‐291 or placebo.Randomization will be stratified by country and baseline injury severity category.Participants will receive once‐daily subcutaneous administration of study treatment for12 weeks, followed by a 4‐week noninterventional follow‐up period. The study is designedto assess treatment effects after completion of the dosing period and to evaluate whetherany observed functional changes persist following treatment discontinuation. Primaryanalysis will be performed at Week 12, with follow‐up through Week 16.In addition to efficacy and safety assessments, the study will characterize thepopulation pharmacokinetics of NVG‐291 in a subset of participants receiving NVG‐291, andwill evaluate patient‐reported outcomes, functional measures, quality‐of‐lifeassessments, and exploratory measures intended to further characterize the potentialeffects of NVG‐291 on recovery following spinal cord injury. An optional open‐labelextension study may be offered following completion of the main study to provide accessto NVG‐291 for participants originally assigned to placebo.