NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury
June 02, 2025 07:00 ET
https://www.globenewswire.com/news-rele ... njury.html
• Study met its primary endpoint by achieving statistical significance on one of its two pre-specified co-primary endpoints, demonstrating increased electrical connectivity between the brain and hand muscle in individuals with a cervical level spinal cord injury (SCI).
• Study also showed a positive trend in the secondary endpoint evaluating change in “GRASSP” score, a measure designed specifically to assess hand function in people with cervical injuries.
• As the first pharmaceutical candidate to show improved motor recovery based on increased motor evoked potential amplitude, these study results represent a significant scientific advance and step forward in the potential to treat SCI, where there remains no approved pharmaceuticals to enable sustained functional recovery.
• Topline safety and efficacy results reinforce the potential of NVG-291 to promote nervous system repair in individuals living with traumatic cervical SCI; NervGen intends to review results and development plan with the U.S Food and Drug Administration (FDA).
• Topline results from the chronic cohort will be presented at the American Spinal Injury Association (ASIA) Annual Scientific Meeting on June 3, 2025.
• Investor and analyst call to review topline data results will be held on June 3, 2025.
VANCOUVER, British Columbia, June 02, 2025 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neuroreparative therapeutics, today announced positive topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. NVG-291 met one of its co-primary endpoints and demonstrated promising changes in “GRASSP” score, a measure designed specifically to assess hand function in individuals with cervical SCI.
Topline results from the trial support the potential of NVG-291 to promote nervous system repair. The trial met a co-primary endpoint demonstrating improved motor connectivity in individuals with cervical chronic SCI receiving NVG-291 (n=10) compared to placebo (n=10). Data showed that subjects receiving NVG-291 achieved a three-fold increase in the strength of motor connectivity to an important hand muscle (first dorsal interosseus), as measured by change in the normalized motor evoked potentials (MEP) amplitude. (Baseline/Week 12 actual results: 6.207/18.773 for NVG-291 vs. 6.527/7.760 for placebo, p-value 0.0155). The second co-primary endpoint evaluating connectivity in a leg muscle (tibialis anterior) did not achieve statistical significance. The co-primary endpoint approach to the trial design is intended to permit only one of the co-primary endpoints to achieve statistical significance, though with a more rigorous p-value of <0.025 being required.
“As a scientist and clinician dedicated to enhancing rehabilitation outcomes for individuals with SCI, I am encouraged by the results from the chronic cohort of the NVG-291 clinical trial,” said Monica A. Perez, PT, Ph.D., Scientific Chair, Arms + Hands Lab, Shirley Ryan AbilityLab and principal investigator of this trial. “A threefold increase in MEP is generally considered substantial and, in this study, the data separation from placebo is clear. I believe that data demonstrating changes in motor connectivity underscore the potential of this new drug candidate to provide functional restoration and improve the quality of life for people with SCI.”
“We are excited to have achieved positive study results demonstrating both improved hand-motor connectivity and improved function in the chronic cohort of our Phase 1b/2a trial. This data supports the therapeutic potential of NVG-291 and represents a big step forward in advancing this drug candidate,” said Mike Kelly, NervGen’s President and Chief Executive Officer. “This data demonstrates, for the first time, that a drug candidate can assist in achieving functional improvement for individuals in the chronic stage of SCI who have plateaued in their recovery. It is important to highlight that changes in upper extremity motor function can provide individuals living with SCI the opportunity for meaningful improvements in their performance of daily functions as well as their independence. Lastly, on behalf of the entire team at NervGen, I would like to thank the investigators, all those involved in the trial at Shirley Ryan AbilityLab, and the individuals with SCI who participated in this trial.”
Positive trends were also seen in the secondary endpoint evaluating the change from baseline in the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Test, with the strongest improvements being in quantitative prehension. GRASSP is a validated test of hand function, sensation and strength comprised of four tests and is designed specifically to assess hand function in individuals with cervical SCI. The quantitative prehension performance subtests scores an individual’s ability to carry out specific gross or fine motor tasks and requires control, orientation of the hand, strength and endurance. A positive trend, though not sufficient to reach statistical significance, toward improvement in the quantitative prehension score was observed (actual change from baseline at week 12: +3.7 for NVG-291 and +0.4 for placebo; linear mixed effects modeled results: +3.1 for NVG-291 1.0 for placebo group, p= 0.1416); 50% of the individuals receiving NVG-291 vs. 10% in the placebo group had an improvement of at least 4 points.
“What I am particularly excited about are the changes in GRASSP scores as these are very important clinical outcomes for patients living with SCI,” said James Guest, MD, PhD, FACS, Professor of Neurological Surgery at the University of Miami. “For individuals with cervical SCI, their level of independence depends on their hand and arm functions. Based on my clinical experience, if an individual with a cervical SCI had to pick what is most important to them, upper extremity function is most often what they would choose. An increase in quantitative prehension can allow for a meaningful improvement in independence.”
In a preliminary post hoc analyses, positive trends toward improvement were also seen for changes on the nine-hole peg test (9-HPT), a measure of upper extremity dexterity. Although not statistically significant based on topline analyses, these results in the secondary endpoints warrant further analysis. We did not see any clear effects on changes in the other secondary endpoints of pinch force, 10-meter Walk Test and Upper and Lower Extremity Motor Scores, although additional analyses are ongoing and have the potential to provide additional insights into the data and NVG-291’s therapeutic effects.
“This is the first placebo-controlled trial of which we are aware that an investigational drug candidate has achieved statistical significance on a primary endpoint, in this case a quantitative biomarker of motor connectivity,” said Daniel Mikol, MD, Ph.D., NervGen’s Chief Medical Officer. “We are highly encouraged by the clear trends in improved GRASSP scores, and we look forward to additional forthcoming analyses to gain further insights into the results already observed. Results from this trial will also guide us in the design of future trials in SCI. We plan to meet with the FDA in the coming months to discuss these results and the path forward for NVG-291. In addition, we continue to enroll participants in the subacute cohort (20-90 days post injury) of the trial.”
We believe that the preliminary efficacy signal observed in the chronic cohort in this study supports clinical advancement of NVG-291 in chronic SCI. NVG-291 was generally safe and well tolerated. The most common adverse event was mild/moderate injection site reactions. There were no treatment discontinuations or serious adverse events in the NVG-291 group.
SCI results in a loss of connectivity that sends and receives electrical signals to and from the brain and can cause changes in feeling, movement, strength, and body functions below the site of injury. NVG-291 is a potential first-in-class therapeutic peptide that targets the body’s natural inhibitors of repair. It is thought to promote natural repair processes (such as axonal regeneration, neuroplasticity, and remyelination) to improve the connections disrupted by SCI. Since there are currently no approved pharmaceuticals to enable functional recovery in SCI, NervGen’s study represents a meaningful and significant step forward for the SCI treatment landscape.
[
Continued]
