NervGen gene therapy slashes functional deficits in spinal cord injury trial

NervGen Pharma (NYSE:NGEN) reported positive results from an independent, blinded biomechanical gait analysis of its Phase 1b/2a CONNECT SCI study, demonstrating that its lead candidate, NVG-291, achieved statistically significant improvements in walking quality among chronic spinal cord injury patients.

The Vancouver, British Columbia-based clinical-stage biotechnology firm announced Tuesday that the specialized motion capture analysis, conducted by AI-driven movement intelligence company Newton Tech, successfully differentiated genuine neural recovery from compensatory physical movements.

The computational findings were independently verified by the Department of Computational Biomedicine at a leading academic medical center.

The study focused on chronic tetraplegia patients who were one to ten years post-injury.

Data from the Global Statistical Test—which integrates established hallmarks of neural recovery including coordination, mechanical effort, and postural stability—revealed a prominent Global Treatment Effect of +0.45 (p=0.0197) for patients treated with NVG-291 compared to the placebo group.

A striking contrast emerged in responder metrics: 100% (10 out of 10) of the subjects receiving NVG-291 met the strict multi-domain criteria to be classified as responders, compared to just 10% (1 out of 10) of the individuals within the placebo cohort (p=0.0001).

All three individual primary recovery subsets tracked by the motion sensors favored the NVG-291 group over placebo.

Inter-joint coordination, assessed via hip-knee cyclogram perimeters, hit a p-value of 0.007.

Mechanical effort, tracking peak joint angular velocity composites, landed at a p-value of 0.038, and postural stability, measured through pelvic tilt variance, charted at p=0.044.

The drug candidate functions as a subcutaneously injected peptide designed to target and block the inhibitory CSPG-PTPσ pathway, a molecular mechanism that naturally prevents the human nervous system from repairing itself following major neurotraumatic events.

NVG-291 has already secured Fast Track designation from the U.S. Food and Drug Administration (FDA).

Financially, the clinical validation lands as a timely catalyst for the company.

NervGen recently uplisted to the Nasdaq Capital Market under the ticker symbol "NGEN" in January 2026, positioning the firm to tap broader institutional capital pools ahead of its next clinical milestone.

Backed by the positive gait analytics and recent regulatory alignment, NervGen confirmed it is finalized to advance NVG-291 into its Phase 3 RESTORE registrational study in chronic tetraplegia.

The randomized, placebo-controlled trial is on track to initiate site activations and patient enrollment by mid-2026.