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NervGen Receives FDA Breakthrough Therapy Designation for NVG-291 in Chronic Spinal Cord Injury

NGEN
  • The FDA granted Breakthrough Therapy designation to NervGen's NVG-291 for treating chronic traumatic cervical motor-incomplete spinal cord injury (SCI).
  • This designation is based on safety & efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study.
  • Preliminary results showed substantial improvements in functional hand use, supported by patient-reported gains in everyday function & independence.
  • NVG-291 was generally well tolerated with no serious adverse events or treatment discontinuations observed in the Phase 1b/2a study.
  • The Phase 3 RESTORE registrational study is currently enrolling approximately 150 participants across the United States & Canada.
  • RESTORE is a randomized, double-blind, placebo-controlled study assessing improvement in hand function as the primary endpoint.
  • Eligible participants for RESTORE must have a traumatic SCI one to ten years prior, a motor level at C7 or higher, & an ASIA Impairment Scale classification of C or D.
  • Participants in the RESTORE study will receive once-daily subcutaneous injections of NVG-291 or placebo for 12 weeks, followed by a four-week observation period.
  • NVG-291 is a first-in-class neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway to facilitate nerve regeneration.
  • The Breakthrough Therapy designation offers benefits including Priority Review eligibility, rolling New Drug Application submissions, & enhanced FDA collaboration.
  • NervGen's NVG-291 also holds Fast Track designation from the FDA & Orphan Drug designation from the European Medicines Agency for SCI treatment.
Company
NervGen Pharma Corp.
Keywords
Nasdaq:NGEN, NervGen Pharma Corp., Biotechnology, Central Nervous System, NGEN, NVG-291, Spinal Cord Injury, Breakthrough Therapy