AbbVie announces that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an investigational treatment for patients following spinal cord injury.
Elezanumab is a monoclonal antibody of the human immunoglobulin (Ig)G1 isotype that binds selectively to repulsive guidance molecule A (RGMa). RGMa is an inhibitor of axonal outgrowth and recognized as an important factor in inhibiting neuronal regeneration and functional recovery following central nervous system (CNS) damage.
Elezanumab is being investigated to treat spinal cord injuries, multiple sclerosis and acute ischemic stroke. It is currently in a phase 2 study for the treatment of spinal cord injury, AbbVie explains in a media release.
“Spinal cord injuries result in devastating lifelong physical, emotional and economic consequences. The FDA’s Orphan Drug and Fast Track Designation for spinal cord injury patients signals an important step forward in AbbVie’s ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients.”
— Michael Gold, MD, Vice President, Neuroscience Development
Partnering in Research and Awareness
Currently AbbVie is partnering with the Shirley Ryan AbilityLab and MC10, a health digital solutions company, in a pilot study involving 20 spinal cord injury patients. The pilot study will inform the ongoing Phase 2 study of elezanumab by testing optimal biosensor placement to capture surface electromyography (sEMG), among other assessments. The pilot study will be completed in approximately 2 months.
AbbVie is also partnering with United Spinal Association and the North American Spinal Cord Injury Consortium to support spinal cord injury awareness and incorporate spinal cord injury community perspectives into clinical research and outreach, the release continues.
[Source(s): AbbVie, PR Newswire]
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