NervGen Pharma Corp. announced that it is on track to complete enrollment in Second Quarter 2024 and deliver the data readout in Third Quarter 2024 of the chronic cohort in the Company's Phase 1b/2a proof-of-concept, double blind, randomized placebo-controlled clinical trial for its proprietary investigational lead compound, NVG-291, in individuals with spinal cord injury (SCI). Preclinical studies of NVG-291 demonstrated functional improvement in both acute and chronic spinal cord injury models of SCI.

The Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions and a pioneer in the use of objective, quantitative electrophysiological based motor connectivity assessments, is the single center for this clinical study. Additionally, NervGen is developing plans to initiate a new study in which subjects completing the current trial who received placebo would have the option to receive open-label NVG-291 under a separate protocol. NervGen plans to initiate this open-label study, provided that an efficacy signal is observed in the chronic cohort, when the cohort is unblinded in the third quarter of 2024 and is contingent upon protocol approval by the U.S. Food and Drug Administration (FDA) as well as the study's Institutional Review Board.

The double blind, 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- 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 trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments that will offset a portion of the direct costs of this clinical trial.