NervGen Pharma announced plans to open clinical trials evaluating the potential of its lead candidate NVG-291 to treat multiple sclerosis (MS) and spinal cord injury.

NVG-291 is an investigational peptide that has shown an ability to stimulate nerve regeneration following an injury in several animal models of disease. It works by inhibiting the activity of the protein tyrosine phosphatase sigma (PTPσ), a neural receptor that blocks nerve regeneration following tissue damage.

NVG-291 is similar in structure, but slightly different in composition, to another PTPσ-targeting compound known as intracellular sigma peptide (ISP).

Previous studies in MS mouse models found that ISP stimulates the production and migration of oligodendrocyte precursor cells (OPCs) — the precursors of cells that produce myelin (the fatty substance that protects nerve segments or axons) — to MS lesions. As a result, ISP promoted myelin repair in damaged nerves, lowered tissue inflammation, and helped animals recover some lost abilities.

NervGen is now planning to explore NVG-291’s nerve regenerative properties and their ability to treat MS and spinal cord injury in people. In a press release, the company announced the next steps in NVG-291’s clinical testing, which include:

A Phase 1 trial assessing the safety and pharmacokinetic properties (how a drug in the body is absorbed, distributed, processed, and eliminated) of the compound in 40 to 75 healthy volunteers; this trial is planned to launch in early 2020.

An expansion of that Phase 1 trial to include a people with spinal cord injury; this extension is scheduled to start in the second half of 2020.

A Phase 2 trial assessing the compound’s safety and effectiveness in a group of MS patients, which is expected to start in early 2021.

“While we continue to evaluate the potential of our platform in additional indications, over the next 24 months we will focus on aggressively advancing the clinical programs for NVG-291 in spinal cord injury and multiple sclerosis,” Ernest Wong, PhD, president and chief executive officer of NervGen, said in the release.

NervGen also intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) before the end of this year, a required step in opening a clinical trial. If that IND is approved, NervGen will proceed with the Phase 1 study in in healthy volunteers.