お知らせ • May 26
NervGen Pharma Corp. Announces Positive Independent Blinded Biomechanical Gait Analyses Demonstrating Genuine Neural Recovery With NVG-291 In Phase 1b/2a CONNECT SCI Study
NervGen Pharma Corp. announced positive independent, blinded biomechanical gait analyses demonstrating genuine neural recovery with NVG-291 in the Phase 1b/2a CONNECT SCI study. NVG-291 demonstrated statistically significant improvement in gait quality (p=0.0197), based on a Global Statistical Test integrating the established hallmarks of genuine neural recovery into a unified assessment of treatment benefit. Based on the Global Statistical Test, 100% (10/10) of NVG-291 subjects were classified as responders across the composite of the hallmarks of genuine neural recovery, versus 10% (1/10) of placebo subjects (p=0.0001). These biomechanical gait findings join reported improvements in electrophysiological signaling, functional hand use, and quality of life, reflecting a consistent, multi-domain pattern of benefit with NVG-291 in the Phase 1b/2a CONNECT SCI study. The biomechanical analyses were conducted by Newton Tech, an AI-powered movement intelligence company specializing in video-based motion capture and computational analysis of standardized walking assessments to produce quantitative measures of gait quality. The metrics evaluated represent established hallmarks of genuine neural recovery: coordination, mechanical effort, and postural stability. The statistical methodology and computational analyses of the resulting data were independently verified by the Department of Computational Biomedicine at a leading academic medical center. Improvements in walking speed arise through two distinct mechanisms: genuine neural recovery, in which the nervous system regains voluntary movement control, or compensation, in which intact muscles exert increased effort. Assessing objective biomechanical movement across these established hallmarks of genuine neural recovery differentiates the two mechanisms: Coordination: The measurement of the hip-knee cyclogram perimeter; how smoothly the hip and knee move together during walking. Neural recovery produces efficient, coordinated movement patterns, while compensation results in decreased control. Mechanical effort: The measurement of peak angular joint velocity; the amount of exertion required from the hip, knee, and ankle to walk. Neural recovery reduces the physical effort needed to achieve the same or greater walking speed, reflecting enhanced neuromuscular control. Postural stability: The measurement of pelvic tilt; the control of the pelvis as weight shifts between legs during walking. Neural recovery is associated with greater balance and stability, while compensation presents as uncontrolled movement. To evaluate these established hallmarks as a unified measure, the Global Statistical Test (GST), a multivariate method that produces a single measure of overall treatment effect, was utilized to compare the treatment effect of NVG-291 versus placebo. In the Phase 1b/2a CONNECT SCI study in chronic tetraplegia (1-10 years post-injury; mean: 3.5 years post-injury), NVG-291 demonstrated a statistically significant treatment effect versus placebo on the multivariate analysis integrating the established hallmarks of genuine neural recovery: Multivariate Global Treatment Effect (GTE): Integrating the established hallmarks of genuine neural recovery into a unified assessment, the GST demonstrated a statistically significant treatment effect favoring NVG-291 (GTE = +0.45; 95% CI: +0.15 to +0.72; p=0.0197), corresponding to a 72.7% probability of treatment benefit with NVG-291 versus placebo. Responder Analysis: Based on the GST, 100% (10/10) of NVG-291 subjects were classified as responders across the composite of the recovery measures of coordination, mechanical effort, and postural stability, compared to just 10% (1/10) of placebo subjects (p=0.0001). A responder was classified as a subject who outperformed the majority of opposite-arm subjects across the composite. Speed-Effort Dissociation: Among placebo subjects, gains in walking speed were statistically correlated with increased mechanical effort (peak knee angular velocity vs. speed: r=+0.83; p=0.003), consistent with compensation. This association was not observed in NVG-291 subjects, consistent with speed gains driven by restored neural control rather than compensatory effort. Consistency Across Recovery Measures: The multivariate treatment effect was consistent across all three recovery measures, with each favoring NVG-291 with statistical significance versus placebo: Coordination, measured by the hip-knee cyclogram perimeter (p=0.007); Mechanical effort, measured by peak joint angular velocity composite (p=0.038); Postural stability, measured by pelvic tilt (p=0.044). Together, these biomechanical gait analyses provide objective and independent evidence of genuine neural recovery with NVG-291, reinforcing the observed clinical benefits in the Phase 1b/2a CONNECT SCI study. In April 2026, NervGen reported a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration and announced alignment on RESTORE, the Company's Phase 3 registrational study evaluating NVG-291 in chronic tetraplegia. The Company plans to maintain dialogue with the FDA and is on track to initiate RESTORE in mid-2026 with site activation underway.
