NervGen Pharma Corp. (TSX-V: NGEN) (OTCQB: NGENF) announced plans to host a virtual investor event on April 9, 2025, focusing on its innovative therapeutic approach to spinal cord injury (SCI) treatment. The event will showcase the company's ongoing Phase 1b/2a clinical trial of NVG-291, a first-in-class therapeutic peptide designed to promote nervous system repair in individuals with spinal cord injuries.
The virtual meeting, scheduled for 10:00 a.m. ET, will feature prominent experts in the field of spinal cord injury rehabilitation and research. Key opinion leaders Dr. Monica Perez from Shirley Ryan AbilityLab and Dr. Steven Kirshblum from Rutgers New Jersey Medical School will join NervGen's management team to discuss the significant unmet medical needs in SCI treatment and the potential impact of NervGen's therapeutic approach.
Addressing a Critical Unmet Need
Spinal cord injuries represent one of the most challenging areas in neurological medicine, with limited treatment options currently available for patients. The condition affects approximately 17,000 new individuals annually in the United States alone, with lifetime care costs often exceeding $5 million per patient for those with severe injuries.
"The current treatment landscape for spinal cord injury remains severely limited, with no approved therapies that can promote significant neurological recovery after injury," said Bill Adams, Chief Financial Officer at NervGen. "Our approach with NVG-291 represents a potential paradigm shift in how we address these devastating injuries."
Innovative Mechanism of Action
NVG-291 represents a novel approach to spinal cord injury treatment. The therapeutic peptide targets protein tyrosine phosphatase sigma (PTPσ), a key inhibitor of neural repair following injury. By blocking this inhibitory pathway, NVG-291 aims to promote multiple repair mechanisms, including neuroplasticity, remyelination, and anti-inflammatory effects.
Preclinical studies with NVG-291-R, the rodent prototype of NVG-291, have demonstrated promising results in animal models of spinal cord injury. These studies have shown the compound's ability to promote functional recovery through multiple mechanisms of neural repair. The technology was originally licensed from Case Western Reserve University and has received Fast Track designation from the U.S. Food and Drug Administration for spinal cord injury.
Phase 1b/2a Clinical Trial Design
The upcoming investor event will provide detailed information about NervGen's ongoing Phase 1b/2a clinical trial (NCT05965700), which is evaluating NVG-291 in two distinct patient populations:
- Chronic SCI patients (1-10 years post-injury)
- Subacute SCI patients (20-90 days post-injury)
This double-blind, placebo-controlled proof-of-concept study is designed to assess both safety and efficacy using a comprehensive set of outcome measures. The trial employs a fixed dose of NVG-291 and utilizes multiple clinical assessments, electrophysiological measurements, MRI imaging, and blood biomarkers to evaluate recovery of function, with a particular focus on motor improvements.
"Our trial design is particularly robust in that it evaluates both objective neurophysiological measures and functional outcomes," explained a company spokesperson. "The primary objective is to assess changes in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment, measured by changes in motor evoked potential amplitudes."
Each cohort will include approximately 20 subjects, with data to be evaluated independently as it becomes available. Clinical results from the trial are expected in the second quarter of this year, potentially providing the first human efficacy data for this novel therapeutic approach.
Expert Perspectives
The upcoming investor event will feature insights from two leading experts in spinal cord injury research and treatment:
Dr. Monica A. Perez serves as the Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab and has over 15 years of experience studying neural mechanisms of movement control in both healthy individuals and those with spinal cord injuries. Her research focuses on understanding brain-spinal cord interactions in movement control, with the goal of developing more effective rehabilitation therapies.
Dr. Steven Kirshblum is Professor and Chair of the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School and serves as chief medical officer for both the Kessler Foundation and Kessler Institute for Rehabilitation. He co-directs the Tim and Caroline Reynolds Center for Spinal Stimulation and is project co-director of the Northern New Jersey Spinal Cord Injury Model System.
Funding Support
The clinical trial is being partially funded through a grant from Wings for Life, an international spinal cord research foundation. The grant is being provided in milestone-based payments and will offset a portion of the direct costs associated with the clinical trial.
Broader Development Pipeline
In addition to its lead program in spinal cord injury, NervGen has initiated preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS), and spinal cord injury. This reflects the company's broader mission to develop neurorestorative therapeutics for various neurological conditions with significant unmet needs.
The virtual investor event will include a live question and answer session following the formal presentations, providing an opportunity for investors and analysts to engage directly with the company's management team and the featured key opinion leaders.
For those interested in attending the virtual event, registration is available through NervGen's website.
