NervGen Pharma Corp. has received Institutional Review Board (IRB) approval for its landmark Phase 1b/2a proof-of-concept clinical trial protocol of its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). NervGen is now actively recruiting potential subjects.

As previously announced, the U.S. Food and Drug Administration (FDA) completed its review of the clinical trial protocol and determined that the study may proceed. This first-in-kind trial is sponsored in part by a grant of up to USD 3.18 million from Wings for Life, a not-for-profit spinal cord injury research foundation. Recruitment of the chronic cohort (1-10 years post-injury) is now open.

The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions. The placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post theinjury) and subacute (10-49 days post-in injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. Each cohort will be evaluated independently as the data becomes available.

The grant funding from Wings for Life, which is to be provided in several milestone-based payments, will offset a portion of the direct costs of this clinical trial. About Wings for Life Accelerated Translational Program. Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research.

The Wings for Life Accelerated Trans Lational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials.