On
'While electrophysiological measures such as MEPs have not been widely used in SCI trials to date, they are objective and quantitative biomarkers of motor connectivity that can be leveraged to monitor motor recovery in investigational trials. The results from our proof-of-concept trial with NVG-291 may provide further evidence of the rationale for using MEPs as an endpoint to evaluate the connectivity of motor pathways following treatment,' said
'Previous preclinical studies in SCI animal models have shown that NVG-291 can promote functional recovery, therefore, we are hopeful that the initial results of the Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable repair of nervous system damage in individuals with SCI and will support the design of a Phase 2/3 trial,' added
Details of the posters are as follows
Title: Electrophysiological Testing as a Surrogate Biomarker of Motor Recovery in Proof-of-Concept SCI Trials
Date: Precourse Session 2 on
Title: A Phase 1b/2a Study of NVG-291 in Individuals with Subacute or Chronic Spinal Cord Injury - Clinical Trial Update
Date: Clinical Trial Updates on
About the NVG-291 Phase 1b/2a Trial
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 (those with a more recent 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.
About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTP). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. NVG-291 has received Fast Track Designation from the FDA in spinal cord injury.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is currently being evaluated in a Phase 1b/2a clinical trial in the company's initial target indication, spinal cord injury.
Contact:
Email: htracey@nervgen.com
Tel: 604.362.6209
Email: info@nervgen.com
Tel: 778.731.1711
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