- Week 16 follow-up data, coupled with blinded exit interviews conducted up to 364 days after the study period, confirm durable
and wide-ranging upper and lower-body improvements compared to placebo - Participant-reported outcomes highlight substantial improvements in bladder control and muscle spasticity compared to placebo
- Statistically significant reduction of hyperactive reticulospinal signaling in upper and lower limbs (via startle MEP), together with previously reported increases in corticospinal signaling (via MEP), establish the biological basis for NVG-291’s clinical efficacy
- Company completed a U.S. Food and Drug Administration (FDA) Type C meeting in September; FDA confirmed that multiple regulatory routes are available to support approval of NVG-291 as the first pharmacologic treatment for spinal cord injury
VANCOUVER, British Columbia – Nov. 24, 2025 – NervGen Pharma Corp. (“NervGen” or the “Company”) (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other traumatic and neurologic disorders, today announced expanded CONNECT SCI Study data demonstrating unprecedented durable improvement in function, independence, and quality of life in individuals living with chronic SCI.
“The expanded CONNECT SCI Study data builds upon our landmark topline results and represents a moment of real hope for the SCI community and a defining milestone for NervGen. NVG-291 continues to demonstrate the ability to restore clinically meaningful function and drive dramatic, real-world improvements in daily independence and quality of life. More importantly, we are observing durable clinical benefits that extend well beyond the 12-week treatment period. Taken together, these findings validate the biologic repair mechanisms first discovered by Dr. Jerry Silver and mark the successful translation of his pioneering work, challenging the long-held belief that the central nervous system cannot repair itself after neurologic trauma,” said Adam Rogers, MD, Interim Chief Executive Officer at NervGen Pharma.
“We recognize that the clinical progress achieved to date and the continued advancement of NVG-291 would not be possible without the support and participation of the SCI community. We are deeply grateful to the individuals and families who placed their trust in NervGen and the Shirley Ryan AbilityLab through their participation in the CONNECT SCI Study. Their courage, commitment and determination have helped to advance the field of neurorepair, bringing us closer to a future where meaningful recovery, even years after SCI, is possible.”
Week 16 and Post-Study Clinical Data from the Phase 1b/2a CONNECT SCI Study
The CONNECT SCI Study was a 16-week placebo-controlled trial in individuals with chronic SCI. Twenty participants (avg. 3.5 years post-injury) were randomized to receive daily subcutaneous NVG-291 or placebo for 12 weeks, followed by a 4-week observation period to assess durability of response at Week 16. In addition, blinded qualitative exit interviews were conducted to provide insight into participants’
real-world experiences and evaluate improvements beyond Week 16.
NVG-291 Functional Gains were Durable and Continued to Improve at and After Week 16
- Functional gains continued to increase four weeks after treatment ended. NVG-291 participants demonstrated a 2.6-fold greater mean improvement in GRASSP Total Score compared to placebo at Week 16.
- Hand function improvements were durable and continued to further strengthen post-treatment, with NVG-291 participants experiencing a 3.7-fold greater mean improvement in GRASSP Quantitative Prehension compared to placebo at Week 16.
- Blinded exit interviews conducted up to 364 days after Week 16 revealed that NVG-291 participants reported more consistent, durable, and wide-ranging functional gains, particularly in upper and lower limb movement, compared to placebo.
- NVG-291 participants further reported that functional improvements often directly enabled greater daily independence and activity, compared to placebo.
Quality of Life Improvements Observed in NVG-291 Participants Following Study Completion
Blinded qualitative exit interviews were conducted by an institutional review board (IRB) approved clinical research organization (CRO). These interviews reinforced and extended the observed quantitative findings, underscoring NVG-291’s potential to deliver clinically meaningful and durable improvements.
- NVG-291 participants reported greater overall improvement on the Participant Global Impression of Change scale.
- 75% (6/8) of NVG-291 participants reported “much” or “very much” improved overall symptoms compared to 33% (3/9) on placebo.
- 67% (6/9) of NVG-291 participants reported improved bladder control compared to 22% (2/9) of placebo participants.
- 56% (5/9) of NVG-291 participants reported reduced muscle spasticity compared to 22% (2/9) of placebo participants.
- NVG-291 participants were more likely than placebo to report sustained improvements across key quality of life domains, including reduced reliance on medications or mobility aids, and greater physical activity tolerance
Blinded Exit Interviews Highlight the Real-World Impact of NVG-291 Treatment1
“I can now take care of myself: brush my hair, brush my teeth, cut my own food. I’ve even started working on art projects. I can open a can of soda, or twist open a bottle of water. All of these were impossible before the study and more importantly, I’ve continued to maintain my improvements.”
– NVG-291 treated participant 158 days after study completion
“Before the study, I couldn’t go four hours without my bladder leaking, and I’d need catheterization every two hours. I used to rely on Botox treatments, but I’m now catheterizing less and continuing to notice improvements in my bladder control.”
– NVG-291 treated participant 360 days after study completion
“I started to notice that I could voluntarily hold my bladder for longer without leaking when not catheterized. I used to experience autonomic dysreflexia when attempting to hold my bladder where my heart would beat faster and I’d begin to sweat. I don’t experience that anymore.”
– NVG-291 treated participant 17 days after study completion
“I used to experience tightness and spasticity throughout my body multiple times a day. I can now move my arms better, my walking has improved now that I feel less tight, and the frequency and severity of the spasms has decreased. These improvements have continued since ending the study.”
– NVG-291 treated participant 350 days after study completion
Statistically Significant Reduction of Hyperactive Reticulospinal Signaling Establish the Biological Basis for NVG-291’s Clinical Efficacy
In SCI, damage to the corticospinal tract, the pathway responsible for fine motor control, forces the reticulospinal tract, which governs involuntary and gross motor movement, to become abnormally hyperactive in compensation. This maladaptive hyperactivity disrupts normal motor signaling and contributes to symptoms such as muscle spasticity and impaired fine motor control.
- NVG-291 treatment produced a statistically significant reduction of hyperactive reticulospinal signaling in both the upper and lower limbs, as measured by startle motor evoked potentials (startle MEPs):
- Leg (tibialis anterior): 142% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0062)
- Hand (first dorsal interosseus): 48% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0280)
- NVG-291 participants demonstrated a statistically significant correlation between reduced hyperactive reticulospinal signaling and strengthened corticospinal signaling in the hands (R = -0.794; p = 0.006), indicating a restored balance between voluntary and involuntary motor pathways.
Together with the previously reported statistically significant increase in upper-limb corticospinal signaling, these findings provide compelling neurophysiological evidence that NVG-291 restores normal communication between motor systems; the biological foundation for the durable improvements in function, daily independence, and quality of life.
Based on the clinical evidence of NVG-291 to reduce hyperactive reticulospinal signaling and muscle spasticity, NervGen has filed a patent application to strengthen the Company’s intellectual property position and further support NVG-291’s broad therapeutic potential.
Expanded CONNECT SCI Study Data Strengthens NVG-291’s Efficacy Profile in Chronic SCI
“The expanded clinical findings from the CONNECT SCI Study mark an exciting advancement for the field of neurorepair and reinforces NVG-291’s potential to enable the nervous system to repair itself after neurologic trauma,” said Randall Kaye, MD, Chief Medical Advisor at NervGen Pharma. “Importantly, the continued improvements in function, daily independence, and quality of life after NVG-291 treatment provides compelling evidence that recovery remains possible, even years after injury. With no approved pharmacologic treatments for SCI, we remain deeply committed to advancing NVG-291 as safely and expeditiously as possible, in collaboration with the SCI community and the FDA, to bring the potential of hope and recovery to this long-overlooked community.”
Update on Recent and Upcoming Regulatory Agency Interactions
The Company completed a productive FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with SCI and the lack of any approved pharmacologic treatments. The Company anticipates an End-of-Phase 2 meeting in early 2026 to further align with the FDA on the development and registration pathway for NVG-291.
Videos Documenting Functional Change Following NVG-291 Treatment in the CONNECT SCI Study
The videos below present visual documentation from the CONNECT SCI Study showing two participants performing a standardized 10-meter walking assessment at baseline and after 12 weeks of NVG-291 treatment. These side-by-side recordings highlight the functional impact of NVG-291 treatment, including observable changes in gait, balance, coordination, and walking efficiency. Additional participant videos, as well as a new corporate presentation highlighting the expanded CONNECT SCI data, are available at https://nervgen.com/presentations/.
(1) Participant remarks paraphrased for brevity from IRB approved, CRO conducted exit interviews
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first- and potential best-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 variant of NVG-291, in animal models of spinal cord injury. These studies implicated multiple 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 and Orphan Designation from the EMA for NVG-291 in individuals with spinal cord injury.
About NervGen
NervGen (TSXV: NGEN, OTCQB: NGENF) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies that enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. The Company is evaluating the clinical efficacy of its first- and potential best-in-class lead candidate, NVG-291, in the Phase 1b/2a CONNECT SCI Study in spinal cord injury. For more information about NervGen, visit www.nervgen.com and follow NervGen on X and LinkedIn for the latest news on the company.