NervGen Brings Advanced Imaging to Planned NVG-291 Trials

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by Patricia Inacio, PhD |

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A partnership will allow NervGen to use Imeka‘s proprietary biomarker imaging technology to precisely measure changes in the brain and spinal cord in its upcoming clinical trials, including a study of NVG-291 in people with multiple sclerosis (MS)

NervGen plans to initiate Phase 1b/2 trials into its lead candidate for neural repair in MS patients, and in people with spinal cord injury, next year. A Phase 1/2a trial is also planned for Alzheimer’s disease.

“We are very excited to apply Imeka’s advanced imaging technology to assess the biological activity of NVG-291 in clinical trials,” Daniel Mikol, MD, PhD, chief medical officer of NervGen, said in a press release.

NVG-291 is an investigational peptide, or a small protein, designed to stimulate nerve regeneration by modulating the activity of the protein tyrosine phosphatase (PTP) sigma, a receptor of nerve cells that blocks nerve regeneration following tissue damage.

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PTP sigma receptors have been shown to halt the repair of nerve cells following an injury, either caused by a disease like MS or as a result of trauma, such as in spinal cord injury.

The compound has shown promising preclinical results in animal models of MS, promoting the regeneration of damaged nerves and boosting remyelination — the restoration of the fatty myelin coating surrounding nerve fibers, which is lost in MS.

“In animal studies, NVG-291 has shown a multi-modal mechanism of action, including enhancement of axonal regeneration, neuroplasticity and remyelination, reflecting its ability to repair the damaged nervous system,” Mikol said.

A Phase 1 clinical trial, taking place in Australia, is currently investigating the safety and pharmacokinetics (movement into, through, and out of the body) of NVG-291 in a group of healthy volunteers.

Participants are receiving one of six ascending doses of the therapy to determine NVG-291’s best therapeutic dose. Top-line data are expected by year’s end on this phase, at which point NervGen anticipates advancing into the study’s multiple ascending dose part.

Should the Phase 1 data be positive, the company plans to launch two Phase 1b/2 clinical trials — one in people with MS and another in those with spinal cord injury — as well as a trial in Alzheimer’s patients. All will apply Imeka’s imaging technology to assess the effectiveness of NVG-291.

“We are very excited to be part of the development of NervGen’s drug, whose novel mechanism of action suggests it could make an enormous difference for patients who have experienced nervous system damage,” said Jean-René Belanger, CEO of Imeka.

Imeka’s technology combines artificial intelligence and free-water diffusion imaging to obtain detailed images of the brain’s white matter, where most of myelin is located and which is the prime target of immune system attacks in MS. This technology allows clinicians to determine the degree of myelin loss.

“Imeka’s imaging technology … allows the very precise measurement of changes to the brain and spinal cord to detect precisely where and how a therapeutic is having its effect,” said Paul Brennan, president and CEO of NervGen.

“Incorporating Imeka’s imaging technology in our clinical trials will nicely complement other outcome measures, including changes in clinical function and fluid biomarkers, to strengthen the evidence supporting that NVG-291 can also repair nervous system damage in humans,” Mikol added.

The two Canadian companies are also submitting research grants to combine their technologies in preclinical and clinical studies into nervous system conditions.

“Recently, we have also worked closely together on several grant applications to various agencies, including the U.S. Department of Defense. We are immensely impressed with the Imeka team and their technology and believe that this partnership will result in a robust and data rich clinical trial program,” Brennan said.

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