The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NervGen Pharma Corp. for NVG-291, a proprietary lead compound aimed at treating spinal cord injury (SCI). This designation is part of the FDA's initiative to accelerate the development and review of drugs that address serious conditions and unmet medical needs, potentially allowing for earlier patient access to innovative treatments.
NVG-291 is a first-in-class therapeutic peptide that targets mechanisms interfering with nervous system repair. It has shown promise in preclinical models by promoting nervous system repair and functional recovery in conditions such as spinal cord injury, peripheral nerve injury, multiple sclerosis, and stroke. The ongoing Phase 1b/2a clinical trial is evaluating NVG-291's efficacy in individuals with cervical spinal cord injury, with initial cohort data expected in mid-2024.
Mike Kelly, NervGen's President & CEO, emphasized the significance of the Fast Track designation, highlighting the potential of NVG-291 to be the first approved treatment enabling neurological and functional recovery post-spinal cord injury. NervGen is committed to working closely with the FDA throughout the clinical development process to expedite the approval and availability of NVG-291.
Fast Track designation offers several benefits, including opportunities for frequent interactions with the FDA review team, eligibility for Priority Review, and the possibility of Accelerated Approval based on surrogate or intermediate clinical endpoints. This designation underscores the urgent need for effective treatments for spinal cord injury and the potential of NVG-291 to meet this critical medical need.
