Top-line Data on NVG-291 in Healthy Volunteers Expected This Year

NervGen Pharma announced that its Phase 1 clinical trial evaluating the safety and pharmacological properties of NVG-291 — its lead therapeutic candidate for multiple sclerosis (MS) and other neurologic conditions — in healthy volunteers is going according to plan, with early top-line data expected later this year.

“The second quarter of 2021 was pivotal for NervGen as we started our Phase 1 clinical trial with NVG-291,” Paul Brennan, NervGen’s president and CEO, said in a press release.

To date, four of the six planned dose groups in the study’s single ascending dose part have been completed, and the fifth dose group is expected to start soon.

According to appropriate dose conversion models, the dose levels of groups four through six “correspond to doses greater than the highest doses tested and found to be efficacious in different animal models of nervous system injury,” Brennan said.

This increases NervGen’s confidence that they “will be in the therapeutic range for the [groups] in the multiple ascending dose portion of the trial,” Brennan added.

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Top-line data from the single ascending dose portion of the study, which dosed its first participant in early May, are expected by year’s end. By that time, NervGen also anticipates to be advancing into the study’s multiple ascending dose part.

The Phase 1 trial, taking place in Australia, is evaluating NVG-291’s safety and pharmacokinetics (its movement into, through, and out of the body) in healthy volunteers. Should the Phase 1 data be positive, the company plans to launch a Phase 2 clinical trial in people with MS next year, plus a Phase 1b trial in Alzheimer’s patients and a Phase 2 study in people with spinal cord injury by next year.

An MS clinical advisory board, comprising six world-class scientific and clinical researchers in the field of MS, was formed in July to advise NervGen on the upcoming trial and the overall MS clinical program.

NVG-291 is a peptide, or a small protein, that works by targeting the protein tyrosine phosphatase sigma, a protein receptor that blocks nerve repair following injury, whether a result of trauma or disease-specific mechanisms, such as in MS or Alzheimer’s disease.

Previous preclinical studies showed that NVG-291 promotes regeneration of damaged nerves and improves their function through several repair mechanisms, such as nerve fiber regeneration, remyelination, and immune modulation.

Remyelination refers to the restoration of myelin, the protective sheath surrounding nerve cell fibers that is lost in MS due to abnormal immune attacks. Preclinical research showed that a NVG-291-like compound promotes remyelination and lessens symptoms in mouse models of MS.

According to NervGen, by targeting nerve cell repair and promoting remyelination, NVG-291 stands out from currently approved MS therapies that work by suppressing the immune system and thereby reducing myelin-targeted immune attacks.