NervGen Pharma Corp. has announced the completion of enrollment for the chronic cohort of its Phase 1b/2a clinical trial, which is evaluating NVG-291 in individuals with spinal cord injury (SCI). The company has also received Institutional Review Board (IRB) approval for amendments to the trial protocol and has begun screening subjects for the subacute cohort.
The Phase 1b/2a trial (NCT05965700) is a double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of NVG-291 in individuals with cervical spinal cord injury. The trial includes two separate cohorts: chronic (1-10 years post-injury) and subacute (20-90 days post-injury). The primary objective is to evaluate the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives include changes in clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements.
Anticipated Topline Results
"We are pleased to share that enrollment is complete in the chronic cohort of our Phase 1b/2a clinical trial in traumatic spinal cord injury," said Daniel Mikol, MD, Ph.D., NervGen’s Chief Medical Officer. "Following the conclusion of the 16-week trial for the last enrolled patient, we can proceed with the next step, which is to ensure all data are thoroughly collected, and reviewed, including database lock, unblinding, and in-depth analysis of the results. When these critical steps are completed, we anticipate announcing topline results in the second quarter of this year."
Advancing to Subacute Cohort
The company has received IRB approval for an amendment to its Phase 1b/2a clinical trial and has initiated the screening of subjects for the subacute cohort of the study. "Completing enrollment for the chronic cohort is an exciting and critical milestone for NervGen," said Mike Kelly, NervGen’s President & CEO. "The team will now shift its focus to enrolling subjects in the subacute cohort. We believe our experience over the past year in recruiting for the chronic cohort together with the recently approved protocol amendment for the subacute cohort should help improve the recruitment process for this second cohort in addition to making the study less burdensome for participants."
About NVG-291
NVG-291 is a first-in-class therapeutic peptide targeting nervous system repair. Preclinical studies of NVG-291-R, the rodent prototype, have demonstrated promotion of neuroplasticity, remyelination, anti-inflammatory polarization of microglia, and functional improvement in animal models of spinal cord injury, stroke, and peripheral nervous system injury. The U.S. Food and Drug Administration has granted Fast Track designation to NVG-291 for spinal cord injury.
NervGen is also initiating preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS) and spinal cord injury.
