Core Insights - NervGen Pharma announced expanded data from the CONNECT SCI Study, showing significant and durable improvements in function, independence, and quality of life for individuals with chronic spinal cord injury (SCI) [2][3][14] Study Overview - The CONNECT SCI Study was a 16-week placebo-controlled trial involving 20 participants with an average of 3.5 years post-injury, who received either NVG-291 or a placebo [5] - Participants were randomized to receive daily subcutaneous NVG-291 for 12 weeks, followed by a 4-week observation period to assess the durability of the response [5] Clinical Efficacy - NVG-291 demonstrated a 2.6-fold greater mean improvement in the GRASSP Total Score compared to placebo at Week 16 [11] - Hand function improvements were 3.7-fold greater in NVG-291 participants compared to placebo at Week 16 [11] - 75% of NVG-291 participants reported "much" or "very much" improved overall symptoms compared to 33% on placebo [11] - 67% of NVG-291 participants reported improved bladder control compared to 22% of placebo participants [11] - 56% of NVG-291 participants reported reduced muscle spasticity compared to 22% of placebo participants [11] Biological Mechanism - NVG-291 treatment resulted in a statistically significant reduction of hyperactive reticulospinal signaling in both upper and lower limbs, establishing a biological basis for its clinical efficacy [10][18] - The treatment also correlated with strengthened corticospinal signaling, indicating restored balance between voluntary and involuntary motor pathways [18] Quality of Life Improvements - Blinded exit interviews highlighted real-world impacts, with participants reporting enhanced daily activities and independence post-treatment [9][8] - Participants noted improvements in bladder control and reduced muscle spasticity, contributing to a better quality of life [9][11] Regulatory Progress - The company completed a Type C meeting with the FDA, confirming multiple regulatory pathways available for NVG-291's approval due to the significant unmet medical need in SCI [15][19] - NervGen has received Fast Track designation from the FDA and Orphan Designation from the EMA for NVG-291 [19] Future Directions - The company anticipates an End-of-Phase 2 meeting in early 2026 to align with the FDA on the development and registration pathway for NVG-291 [15]