NervGen reports topline data from chronic cohort of Phase 1b/2a trial of NVG-291

NervGen Pharma (NGENF) announced topline results from the chronic cohort of its Phase 1b/2a clinical trial evaluating its lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. NVG-291 met one of its co-primary endpoints and demonstrated promising changes in “GRASSP” score, a measure designed specifically to assess hand function in individuals with cervical SCI. Topline results from the trial support the potential of NVG-291 to promote nervous system repair. The trial met a co-primary endpoint demonstrating improved motor connectivity in individuals with cervical chronic SCI receiving NVG-291 compared to placebo. Data showed that subjects receiving NVG-291 achieved a three-fold increase in the strength of motor connectivity to an important hand muscle, as measured by change in the normalized motor evoked potentials amplitude. The second co-primary endpoint evaluating connectivity in a leg muscle did not achieve statistical significance. The co-primary endpoint approach to the trial design is intended to permit only one of the co-primary endpoints to achieve statistical significance, though with a more rigorous p-value of less than0.025 being required. Positive trends were also seen in the secondary endpoint evaluating the change from baseline in the Graded Redefined Assessment of Strength, Sensation and Prehension Test, with the strongest improvements being in quantitative prehension. GRASSP is a validated test of hand function, sensation and strength comprised of four tests and is designed specifically to assess hand function in individuals with cervical SCI. The quantitative prehension performance subtests scores an individual’s ability to carry out specific gross or fine motor tasks and requires control, orientation of the hand, strength and endurance. A positive trend, though not sufficient to reach statistical significance, toward improvement in the quantitative prehension score was observed; 50% of the individuals receiving NVG-291 vs. 10% in the placebo group had an improvement of at least 4 points. In a preliminary post hoc analyses, positive trends toward improvement were also seen for changes on the nine-hole peg test, a measure of upper extremity dexterity. Although not statistically significant based on topline analyses, these results in the secondary endpoints warrant further analysis. We did not see any clear effects on changes in the other secondary endpoints of pinch force, 10-meter Walk Test and Upper and Lower Extremity Motor Scores, although additional analyses are ongoing and have the potential to provide additional insights into the data and NVG-291’s therapeutic effects. NVG-291 was generally safe and well tolerated. The most common adverse event was mild/moderate injection site reactions. There were no treatment discontinuations or serious adverse events in the NVG-291 group.