NervGen Completes Key Milestone In Spinal Cord Injury Trial

NervGen Pharma Corp, a biotech company focused on developing therapies to restore nerve function, has reached an important milestone in its Phase 1b/2a clinical trial for NVG-291, its leading drug candidate for spinal cord injury (SCI). The company announced the enrollment of the 20th and final participant in the chronic cohort of this proof-of-concept, double-blind, randomised, placebo-controlled trial.

Daniel Mikol, MD, PhD, NervGen’s Chief Medical Officer, said in a statement, “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. Following the conclusion of the 16-week trial for the last enrolled patient, we can proceed with the next step, ensuring 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.”

In addition to completing enrollment for the chronic cohort, NervGen has received IRB approval to amend the ongoing trial. This approval paves the way for the company to move forward with screening participants for the subacute cohort of the study. These advancements highlight NervGen’s commitment to developing innovative neurorestorative treatments that could significantly improve the lives of individuals with spinal cord injuries.

Mike Kelly, NervGen’s President & CEO, said, “Completing enrollment for the chronic cohort is an exciting and critical milestone for NervGen. The team will now focus on enrolling subjects in the subacute cohort. We believe our experience over the past year in recruiting for the chronic cohort and the recently approved protocol amendment for the subacute cohort should help improve the recruitment process for this second cohort and make the study less burdensome for participants.”

Mr Kelly also commented, “This milestone is a great way to start the year as we advance our clinical development efforts. We’ve made significant progress in 2024, and 2025 is poised to be a pivotal year for both NervGen and the SCI community. We remain fully committed to advancing NVG-291 through the clinical and regulatory process to eventually make it widely available to individuals living with SCI, the vast majority of whom remain without any therapeutic options.”