NervGen Pharma Corp. is nearing completion of target enrollment for the chronic cohort in its Phase 1b/2a proof-of-concept clinical trial evaluating NVG-291 in individuals with spinal cord injury (SCI). This double-blind, randomized, placebo-controlled trial (NCT05965700) is designed to assess the efficacy of NVG-291 in both chronic (1-10 years post-injury) and subacute cervical SCI patients.
Trial Design and Objectives
The Phase 1b/2a trial is evaluating a fixed dose of NVG-291, focusing on improvements in motor function. The primary objective is to assess changes in corticospinal connectivity of defined upper and lower extremity muscle groups based on changes in motor evoked potential amplitudes. Secondary objectives include evaluating changes in motor function, upper extremity dexterity, grasping, mobility, and additional electrophysiological measurements. The trial is being partially funded by a grant from Wings for Life.
About NVG-291
NVG-291 is a first-in-class therapeutic peptide that targets mechanisms interfering with nervous system repair. It is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPσ). Preclinical studies with NVG-291-R, a rodent analog, have demonstrated promotion of nervous system repair and functional recovery in animal models of SCI, peripheral nerve injury, multiple sclerosis, and stroke, through enhanced plasticity, axonal regeneration, and remyelination. The U.S. Food and Drug Administration has granted Fast Track Designation to NVG-291 for spinal cord injury.
Company Comments
"We are excited to be near completion of enrollment in the chronic cohort of our Phase 1b/2a study in SCI," said Mike Kelly, NervGen's President & CEO. "Our ongoing recruitment efforts continue to attract potential study participants into the screening process... We remain confident in our efforts to advance NVG-291 and will further advise when enrollment has completed and when topline data is expected."
NervGen intends to allow all subjects who have initiated the screening process when the 20-subject target is achieved to enroll in the study if they meet the entry criteria, potentially resulting in more than 20 subjects being enrolled in the chronic cohort.
