NervGen reported positive blinded biomechanical analyses from the Phase 1b/2a CONNECT SCI study showing NVG-291 improved gait quality and neural recovery measures in chronic tetraplegia patients.
Written by: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
NervGen Pharma today announced positive independent, blinded biomechanical gait analyses demonstrating genuine neural recovery with NVG-291 in the Phase 1b/2a CONNECT SCI study (NCT05965700) in chronic tetraplegia.
The analyses demonstrated statistically significant improvements in gait quality favoring NVG-291 versus placebo and provided objective evidence that the therapy may promote restoration of underlying neural control rather than compensatory movement strategies. Subjects enrolled in the study were 1–10 years post-injury, with a mean injury duration of 3.5 years.
The biomechanical analyses were independently conducted by Newton Tech, an AI-powered movement intelligence company specializing in video-based motion capture and computational analysis of standardized walking assessments. The evaluated metrics represented recognized hallmarks of genuine neural recovery, including coordination, mechanical effort, and postural stability. Statistical methodology and computational analyses were independently verified by the Department of Computational Biomedicine at a leading academic medical center.
The Global Statistical Test (GST), a multivariate analysis integrating all three hallmarks of recovery into a unified assessment of treatment benefit, demonstrated a statistically significant treatment effect favoring NVG-291 over placebo (GTE = +0.45; 95% CI: +0.15 to +0.72; p=0.0197), corresponding to a 72.7% probability of treatment benefit.
Responder analysis further differentiated NVG-291 from placebo. Based on the GST composite, 100% (10/10) of NVG-291-treated subjects were classified as responders across coordination, mechanical effort, and postural stability measures, compared with 10% (1/10) of placebo-treated subjects (p=0.0001).
Improvements in walking speed may occur through genuine neural recovery or compensation, where intact muscles exert greater effort to achieve movement. The study demonstrated that placebo subjects showed statistically significant correlation between walking speed gains and increased mechanical effort (peak knee angular velocity versus speed: r=+0.83; p=0.003), consistent with compensatory movement. This association was not observed in NVG-291-treated subjects, suggesting that speed improvements were driven by restored neural control rather than increased exertion.
The treatment effect consistently favored NVG-291 across all evaluated recovery measures, including coordination measured by hip-knee cyclogram perimeter (p=0.007), mechanical effort measured by peak joint angular velocity composite (p=0.038), and postural stability measured by pelvic tilt (p=0.044).
“These results provide independent and objective evidence that NVG-291 is promoting genuine neural recovery reflected in lower-body locomotor function,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “In a chronic population where, meaningful natural recovery has largely plateaued, these findings strengthen the growing evidence supporting NVG-291 as a potentially best-in-class restorative therapy for chronic tetraplegia.”
Armin Curt, MD, Clinical Director of the SCI Center at Balgrist University Hospital, Zürich, stated that distinguishing genuine neural recovery from compensation has long represented a major challenge in SCI and movement disorders research. He noted that the multi-domain biomechanical signature observed in the study is consistent with the pattern expected from therapies capable of restoring underlying neural function.
The biomechanical findings complement previously reported improvements in electrophysiological signaling, functional hand use, and quality of life observed in the CONNECT SCI study. Together, the results reinforce the therapeutic profile of NVG-291 and support its advancement into the Phase 3 RESTORE registrational study in chronic tetraplegia. NervGen previously announced successful completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration and remains on track to initiate RESTORE in mid-2026 with site activation underway.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.