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NervGen Pharma Announces Successful End-of-Phase 2 Meeting and FDA Alignment on RESTORE, a Phase 3 Registrational Study of NVG-291 for Chronic Tetraplegia

NGEN
  • NervGen Pharma achieved FDA alignment on the RESTORE Phase 3 registrational study parameters for NVG-291 in chronic tetraplegia.
  • RESTORE is a 16-week, randomized, double-blind, placebo-controlled trial enrolling approximately 150 adults with chronic tetraplegia.
  • The primary endpoint is the change from baseline in GRASSP Quantitative Prehension at Week 12.
  • Key secondary endpoints include Patient/clinician global impressions of change, SCIM-III, lower extremity spasticity, & blinded qualitative interviews.
  • Study initiation is on-track for mid-2026 with activities currently underway.
  • CONNECT SCI Phase 1b/2a data showed a +3.3-point treatment difference in GRASSP QtP at Week 12, exceeding the minimally important difference.
  • Sustained treatment effects were observed at Week 16, four weeks after cessation of the 12-week daily subcutaneous dosing regimen.
  • NervGen concluded enrollment in the subacute tetraplegia cohort of the CONNECT SCI study & plans to unblind available data.
  • The company intends to apply the RESTORE regulatory framework to inform a future registrational study in subacute tetraplegia.
  • NVG-291 holds FDA Fast Track designation & European Medicines Agency Orphan Drug designation for spinal cord injury.