NervGen Pharma to Present at ASIA 51st Annual Meeting

NervGen Pharma Corp., a biotech company focused on developing treatments for nervous system damage, announced that their Chief Medical Officer, Dr. Daniel Mikol, will present two posters at the American Spinal Injury Association's (ASIA) 51st Annual Scientific Meeting in San Juan, Puerto Rico, from May 20-23, 2024. The event gathers experts from various disciplines to enhance communication, collaboration, and research aimed at improving spinal cord injury (SCI) care.

Dr. Mikol's first presentation, scheduled for May 20, will discuss preclinical and clinical data pointing to a correlation between improvements in motor evoked potentials (MEPs) and motor recovery post-SCI. He will suggest that MEPs could serve as efficacy biomarkers in SCI clinical trials. On May 21, Dr. Mikol will present an update on the baseline demographic and clinical characteristics of initial participants in NervGen's ongoing Phase 1b/2a clinical trial (NCT05965700) at Shirley Ryan AbilityLab in Chicago. This study evaluates NVG-291 in both chronic (1-10 years post-injury) and subacute SCI subjects by using electrophysiological measures, including MEPs, to monitor motor recovery.

Dr. Mikol highlighted that electrophysiological measures like MEPs, though not widely used in SCI trials, offer objective and quantitative data on motor connectivity. These measures could effectively monitor motor recovery in clinical settings. The results from the NVG-291 proof-of-concept trial could support the use of MEPs as endpoints for evaluating motor pathway connectivity post-treatment. He emphasized that detecting an efficacy signal on a surrogate biomarker like MEP could provide evidence that NVG-291 induces biological changes predictive of clinical efficacy.

Mike Kelly, NervGen's President & CEO, noted that preclinical studies in animal models have shown NVG-291 can promote functional recovery. He expressed hope that initial results from the Phase 1b/2a trial will demonstrate NVG-291's potential to repair nervous system damage in humans with SCI, potentially leading to a Phase 2/3 trial design.

The NVG-291 Phase 1b/2a trial is a double-blind, placebo-controlled study evaluating NVG-291's efficacy in two cohorts: chronic and subacute SCI patients. The trial uses a single-center approach to minimize variability in electrophysiological measurements. The primary focus is on changes in MEP amplitudes to assess corticospinal connectivity. Secondary objectives include evaluating motor function, dexterity, grasping, mobility, and other electrophysiological measures. The trial is partially funded by Wings for Life, with payments based on achieving specific milestones.

Shirley Ryan AbilityLab, previously known as the Rehabilitation Institute of Chicago, is renowned for its leadership in physical medicine and rehabilitation. It has been named the "No. 1 Rehabilitation Hospital in America" by U.S. News & World Report since 1991. The facility, which opened in 2017, integrates clinicians, scientists, and technologists to work collaboratively, providing patients with access to cutting-edge research and treatment around the clock.

NervGen holds exclusive global rights to NVG-291, a peptide designed to target mechanisms hindering nervous system repair. Derived from the receptor type protein tyrosine phosphatase sigma (PTPσ), NVG-291 has shown promise in preclinical models for various conditions, including SCI, peripheral nerve injury, multiple sclerosis, and stroke. The drug has received Fast Track Designation from the FDA for spinal cord injury.

NervGen is dedicated to developing treatments that enable the nervous system to repair itself following trauma or disease. Their leading drug candidate, NVG-291, is currently under evaluation in a Phase 1b/2a clinical trial for spinal cord injury.