Dr. Daniel Mikol reports

NERVGEN PHARMA TO PRESENT TOPLINE DATA FOR NVG-291 PHASE 1B/2A CHRONIC COHORT STUDY AT THE AMERICAN SPINAL INJURY ASSOCIATION ANNUAL SCIENTIFIC MEETING

Nervgen Pharma Corp. will present top-line results from the chronic cohort of the continuing phase 1b/2a study of NVG-291 as an oral presentation at the 52nd American Spinal Injury Association annual scientific meeting being held June 2 to June 4, 2025, in Scottsdale, Ariz.

"We are looking forward to completing the data analysis, unblinding the data and presenting the first results from the chronic cohort in this initial proof-of-concept, double-blind, placebo-controlled clinical trial of NVG-291 in spinal cord injury (SCI)," stated Dr. Daniel Mikol, MD, PhD, Nervgen's chief medical officer. "In this trial, we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the chronic cohort of our phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI."

Presentation details

Presenting author:   Dr. Daniel Mikol, MD, PhD, chief medical officer, Nervgen

Presentation title:  a 16-week placebo-controlled phase 1b/2a study of NVG-291: results for the chronic cohort

Session name:  General Session 6: Clinical Trial Updates; Clinical Trials: What's the Latest and When Will it Get Here?

Session date:  Tuesday, June 3, 2025

Session time:  10:40 a.m. to 11:40 a.m. MST

Location:  Arizona Ballroom I, Grand Hyatt Scottsdale Resort, 7500 E Doubletree Ranch Rd., Scottsdale, Ariz.

About NVG-291

Nervgen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination and promotion of a non-inflammatory phenotype in the microglial cells. Nervgen has received fast-track designation from the FDA (U.S. Food and Drug Administration) for NVG-291 in individuals with spinal cord injury.

About phase 1b/2a trial

The double-blind, placebo-controlled, proof-of-concept phase 1b/2a clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete spinal cord injury: chronic (one to 10 years postinjury) and subacute (20 to 90 days postinjury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the safety and efficacy of a fixed dose of NVG-291 using electrophysiological imaging and MRI (magnetic resonance imaging) measures, functional clinical outcome measures, and blood biomarkers that together will provide comprehensive information about the extent of recovery of somatic and autonomic function postinjury. Specifically, the primary objective seeks to assess changes in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment, based on changes in motor-evoked potential amplitudes. Secondary objectives evaluate changes in multiple clinical outcome assessments focusing on motor function, upper extremity dexterity, grasping and immobility, and additional electrophysiological measurements. The cohorts will comprise 20 subjects each and will be evaluated independently in a blinded manner as the data become available. The trial is being partially financed by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.

About Nervgen Pharma Corp.

Nervgen is a clinical-stage biotech company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease. The company is testing the clinical efficacy of its lead candidate, NVG-291, in a phase 1b/2a clinical trial in spinal cord injury and has initiated preclinical test of concept evaluation of the company's pipeline candidate, NVG-300, in models of ischemic stroke and spinal cord injury.

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