NVG-291 is designed to promote the repair and regeneration of lost myelin. The investigational therapy works by modulating an enzyme called tyrosine phosphatase sigma. This enzyme normally blocks nerve repair following injury, either due to trauma or disease-specific processes such as MS or Alzheimer’s disease.
Previous preclinical studies demonstrated that NVG-291 promoted the regeneration of damaged nerves and improved their function via repair mechanisms, including nerve fiber regeneration, remyelination, and lessened inflammation.
“These results continue to exceed our expectations. Not only is NVG-291 well tolerated, the positive pharmacokinetic characteristics that were reported previously appear to be maintained at the highest dose,” said Paul Brennan, NervGen’s president and CEO.
“We believe that this data provides us with very strong rationale to proceed to the MAD portion of the study, and provides us with a great deal of confidence that the efficacy results seen in multiple preclinical disease and injury models will translate to positive results in our upcoming clinical trials in Alzheimer’s disease, multiple sclerosis and spinal cord injury patients which we plan to start in 2022,” he said.
"....NVG-291, a protein tyrosine phosphatase (PTPσ) modulator, has demonstrated the potential to promote repair mechanisms in the central nervous system such as axonal regeneration; remyelination; plasticity; autophagy (a cellular self-cleaning mechanism that removes unnecessary or dysfunctional components); and a non-inflammatory phenotype in microglia cells, the innate immune cells of the brain. PTPσ is a protein which has been shown to impede repair following injury to the nervous system. Nervous system injury can occur because of trauma, such as in the case of spinal cord injury or traumatic brain injury, or as a result of disease-specific mechanisms, such as multiple sclerosis or Alzheimer's disease.
A Phase 1 trial of NVG-291 in heathy subjects is ongoing and, upon completion of the multiple ascending dose portion of the trial, NervGen intends to initiate a Phase 1b/2a trial in Alzheimer's disease patients. Concurrently, the Company also plans to initiate Phase 1b/2 trials in spinal cord injury and multiple sclerosis with each of these trials planned to start in 2022....."
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