NervGen Pharma Announces Expanded CONNECT SCI Study Data Demonstrating Unprecedented Durable Improvement in Function, Independence, and Quality of Life in Chronic Spinal Cord Injury

Executive Summary

• NervGen Pharma announced expanded data from its Phase 1b/2a CONNECT SCI Study showing durable, statistically significant functional improvements in chronic spinal‑cord‑injury (SCI) patients treated with NVG‑291 versus placebo.
• Participants reported 2.6‑fold greater gains in overall hand function (GRASSP Total Score) and 3.7‑fold greater gains in quantitative prehension at Week 16, with benefits persisting up to 364 days post‑treatment.
• The FDA confirmed multiple regulatory pathways for NVG‑291, underscoring a clear path toward accelerated approval of the first pharmacologic therapy for SCI.

Key Details

• Study Design: 16‑week, double‑blind, placebo‑controlled trial; 20 participants (average 3.5 years post‑injury) received daily subcutaneous NVG‑291 or placebo for 12 weeks plus a 4‑week observation period.
• Functional Outcomes – Week 16:
• GRASSP Total Score: 2.6× greater mean improvement vs. placebo.
• GRASSP Quantitative Prehension (hand function): 3.7× greater mean improvement vs. placebo.
• Durability: Blinded exit interviews up to 364 days post‑Week 16 showed continued functional gains, increased independence, and reduced reliance on assistive devices.
• Quality‑of‑Life Metrics:
• Participant Global Impression of Change – 75% (6/8) NVG‑291 participants reported “much” or “very much” improvement vs. 33% (3/9) placebo.
• Bladder control improvement: 67% (6/9) NVG‑291 vs. 22% (2/9) placebo.
• Muscle spasticity reduction: 56% (5/9) NVG‑291 vs. 22% (2/9) placebo.
• Neurophysiological Findings:
• Startle MEPs showed a 142 % greater reduction in hyperactive reticulospinal signaling in the tibialis anterior (p=0.0062).
• Hand (first dorsal interosseus) showed a 48 % greater reduction (p=0.0280).
• Strong inverse correlation between reduced reticulospinal activity and increased corticospinal signaling in hands (R = ‑0.794, p = 0.006).
• Regulatory Update: Completed FDA Type C meeting (Sept 2024); FDA indicated multiple pathways (including accelerated approval) are available for NVG‑291 given the unmet need. Anticipated End‑of‑Phase 2 meeting in early 2026.
• Intellectual Property: Patent application filed to broaden IP protection around NVG‑291’s therapeutic mechanisms.
• Additional Materials: Video documentation of 10‑meter walking assessments (baseline vs. post‑treatment) available at https://nervgen.com/presentations/.

Notable Quotes

“NVG‑291 continues to demonstrate the ability to restore clinically meaningful function and drive dramatic, real‑world improvements in daily independence and quality of life.” – Adam Rogers, MD, Interim CEO, NervGen Pharma

“The continued improvements… provide compelling evidence that recovery remains possible, even years after injury.” – Randall Kaye, MD, Chief Medical Advisor, NervGen Pharma