NervGen Pharma Highlights Clinical Trial Challenges in Spinal Cord Injury at U2FP Symposium
Key Insights
NervGen Pharma's CMO, Dr. Daniel Mikol, will present at the U2FP Symposium, addressing challenges in translating SCI animal model results to human clinical trials.
NVG-291, NervGen's therapeutic peptide, targets nervous system repair mechanisms and has shown promise in preclinical models of spinal cord injury (search).
A Phase 1b/2a trial (NCT05965700) is underway to evaluate NVG-291's efficacy in chronic and subacute cervical spinal cord injury (search), focusing on motor function improvements.
NervGen Pharma Corp. is set to present at the Unite 2 Fight Paralysis (U2FP) 19th Annual Science & Advocacy Symposium in Atlanta, Georgia, on September 27-28, 2024. Dr. Daniel Mikol, NervGen’s Chief Medical Officer, will discuss the hurdles in translating spinal cord injury (search) (SCI) research from animal models to successful human clinical trials. His presentation, titled "Clinical Trials in Spinal Cord Injury … Lost in Translation?", will take place on September 28.
Addressing Translation Challenges in SCI Clinical Trials
Dr. Mikol emphasized the difficulties in bridging the gap between animal model results and clinical outcomes for SCI patients. The U2FP symposium aims to unite researchers, clinicians, investors, SCI survivors, and their families to advance SCI treatment and research.
NVG-291: A Promising Therapeutic for Nervous System Repair
NervGen's lead drug candidate, NVG-291, is a first-in-class therapeutic peptide designed to promote nervous system repair. It targets mechanisms that interfere with the body's natural ability to recover from nerve damage. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPσ (search)).
Preclinical studies using NVG-291-R, a rodent analog, have demonstrated enhanced plasticity, axonal regeneration, and remyelination in animal models of spinal cord injury (search), peripheral nerve injury, multiple sclerosis (search), and stroke (search). The U.S. Food and Drug Administration has granted Fast Track Designation to NVG-291 for spinal cord injury.
Phase 1b/2a Trial Evaluating NVG-291 in Spinal Cord Injury
A Phase 1b/2a double-blind, placebo-controlled trial (NCT05965700) is currently evaluating the efficacy of NVG-291 in individuals with cervical spinal cord injury (search). The trial includes two cohorts: those with chronic (1-10 years post-injury) and subacute injuries. The study design reflects preclinical findings showing efficacy in both chronic and acute SCI models.
The trial aims to assess the impact of a fixed dose of NVG-291 on corticospinal connectivity using motor evoked potential amplitudes. Secondary objectives include evaluating changes in motor function, upper extremity dexterity, grasping, and mobility through clinical outcome assessments and electrophysiological measurements. Each cohort will be assessed independently as data becomes available. The trial is partially funded by a grant from Wings for Life.