- NervGen Pharma Corp. (NGEN) has received approval to advance to the final dose cohort in the Phase 1 clinical trial of NVG-291
- NervGen will now proceed to evaluate the highest dose level of NVG-291 in the third MAD cohort
- Following completion of the third MAD dose cohort, NervGen will seek removal of the partial clinical trial hold initiated by the FDA
- NervGen Pharma Corp. (NGEN) opened trading at C$2.17 per share
NervGen Pharma Corp. (NGEN) has received approval to advance to the final dose cohort in the Phase 1 Clinical Trial of NVG-291.
In preclinical animal studies, NVG-291 has demonstrated the potential to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination, and plasticity.
“This second cohort in the MAD portion of our Phase 1 was a success in multiple ways,” stated Paul Brennan, NervGen’s President & CEO.
“As with our other cohorts, we did not have any adverse events reported in this cohort that were either serious or severe. This is very encouraging as we plan for our upcoming patient studies since we have now demonstrated that NVG-291 is well tolerated after 14 days of administration at doses well above those found to be efficacious in animals. This provides us with a clear pathway to define our doses as we plan for our upcoming Phase 1b/2a efficacy studies in Alzheimer’s disease and spinal cord injury patients later in 2022 and a Phase 2 study in multiple sclerosis patients in early 2023.”
Mr. Brennan continued, “It is significant that the doses of NVG-291 administered in the second MAD cohort were 80 per cent higher than the highest corresponding dose found to be efficacious in animal models and over 50 times higher than the lowest efficacious doses where functional improvements were observed.”
NervGen will now proceed to evaluate the highest dose level of NVG-291 in the third MAD cohort. This next step will provide greater flexibility in establishing doses for future patient studies and will provide additional important information about the safety and pharmacokinetic profile of NVG-291.
Following completion of the third MAD dose cohort and ongoing toxicology studies requested by the United States Food and Drug Administration (FDA), NervGen will seek removal of the partial clinical trial hold initiated by the FDA and evaluate bridging cohorts of healthy males and healthy premenopausal females.
NervGen holds the exclusive worldwide rights to NVG-291 and is developing a unique new class of drugs around the technology. The company’s initial focus is on spinal cord injury, Alzheimer’s disease and multiple sclerosis.
NervGen Pharma Corp. (NGEN) opened trading at C$2.17 per share.