NervGen Pharma Corp. is a biotechnology company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease, with a primary focus on spinal cord injury.
NervGen Pharma is working on promoting repair of the nervous system in a completely unique way. Can you explain your approach and how it differs from existing therapies?
When I first spoke with Dr. Jerry Silver, our technology’s founder, I had to do a lot of homework to understand his discoveries. In simple terms, Dr. Silver found that when the central nervous system is damaged, the body inhibits repair instead of promoting it. He identified a group of molecules called chondroitin sulfate proteoglycans (CSPGs) that prevent nervous system repair, remyelination, and plasticity—three key processes needed for recovery.
NVG-291 is a peptide discovered in Jerry Silver’s Lab at Case Western Reserve University, that is derived from the intracellular wedge domain of the CSPG receptor protein tyrosine phosphatase sigma (PTPσ).
In his and other academic publications, the rodent prototype of NVG-291, termed ISP, has been reported to interfere with CSPG signaling and promote axonal repair, myelination, and neuroplasticity.
Your lead candidate is focused on spinal cord injury, which is a traumatic injury rather than a disease. Does your approach have broader applications?
Although spinal cord injury is our initial focus, the same biological mechanisms could possibly apply to multiple conditions. NVG-291-R demonstrated efficacy in various preclinical models, including chronic and acute spinal cord injury, stroke, multiple sclerosis, and peripheral nerve injury. In several of these preclinical models, it showed improvement in enhanced plasticity, axonal and myelination repair, and recovery of locomotor and bladder function which could suggest that our approach could possibly be applied to other neurological conditions.
As a small company, we had to be strategic about where to start, so we chose chronic spinal cord injury as our proof-of-concept indication. In addition, we have initiated a preclinical evaluation of a new proprietary molecule discovered at NervGen, NVG-300, in models of stroke and amyotrophic lateral sclerosis (ALS). If our upcoming data readouts are positive, they could open the door for us to expand into multiple disease areas.
What are your expectations in terms of efficacy?
Our primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential (MEP) amplitudes. MEPs measure connectivity—specifically, the strength and speed of signals traveling from the motor cortex in the brain to muscles in upper and lower extremities. Stronger signals suggest nervous system repair, while faster signals indicate remyelination. If we can show an increase in signal strength and speed, it could be a major breakthrough.
The secondary endpoints are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. If we achieve both, it could not only validate our approach for spinal cord injury but might also provide a foundation for future pivotal trials.
Has your approach piqued the interest of large pharmaceutical companies?
Many companies are working on treatments for central nervous system disorders and we believe our approach is novel. Similar to other development companies, we will approach partnering opportunities as our programs advance. Interest from pharmaceutical companies has increased, especially following the JP Morgan Healthcare Conference in January 2025. In the past, we were actively reaching out to get our story heard. Now, with enrollment completed in the chronic cohort of our spinal cord injury trial and a data readout just months away, potential partners are coming to us.
We are educating them on how our approach could translate across multiple indications, and while it is too early to say if a partnership will materialize, the conversations have been encouraging.
Finally, if we speak again next year, how do you hope NervGen will look at that point?
We recently reported the completion of enrollment in the chronic cohort (1-10 years post-injury) of our Phase 1b/2a proof-of-concept clinical trial in subjects living with spinal cord injury. We are targeting to announce the results for this cohort in Q2 2025. We also announced that the first subject has been enrolled in the subacute cohort (20-90 days post-injury) of this study. Lastly, we plan to announce results of the preclinical studies being conducted with NVG-300 in ALS and stroke. All this being said, this is a big year for NervGen, and next year, I hope to see all of our programs advancing to the next stage of development. Our goal is to continue to advance and eventually bring solutions to significant unmet medical needs to the market.
If our upcoming proof-of-concept data is positive, it could be transformative—not just for NervGen, but for the field of neuroregeneration. We are well-positioned to move forward, and I believe we have the potential to bring new treatments to patients who currently have no options.
