NervGen Pharma Corp. announced that it has been awarded a grant of up to $3.18 million from Wings for Life, a not-for-profit spinal cord injury research foundation, under the foundation's Accelerated Translational Program. The funding will support the upcoming Phase 1b/2a proof of concept clinical trial for the Company's proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI).

Additionally, the U.S. Food and Drug Administration (FDA) has completed their review of the Company's clinical trial protocol and has determined that the study may proceed. The Company will continue to work to resolve the ongoing partial clinical hold from the FDA, but the hold does not impact the conduct of this trial. The placebo-controlled proof of concept trial will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10- 49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury.

The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers, that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess 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 are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements.

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.