AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and Fast Track Designation for Spinal Cord Injury

Shots:  

• The US FDA has granted ODD and FT destination to Elezanumab, which is an investigational treatment for patients following spinal cord injury
• The company is collaborating with Shirley Ryan AbilityLab and MC10 to evaluate elezanumab in a pilot study in 20 spinal cord injury patients. The pilot study will inform the ongoing P-II study of therapy by testing optimal biosensor placement to capture sEMG, among other assessments, and is expected to be completed in ~2mos.
• Elezanumab is a mAb of IgG1 isotype that binds selectively to RGMa, acts by inhibiting neuronal regeneration and functional recovery following CNS damage, currently being investigated spinal cord injuries, MS and AIS

Click here ­to­ read full press release/ article | Ref: AbbVie | Image: StraitTimes