The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(tokyo:4592), a scientific leader in regenerative medicine for neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation for SB623 cell therapy for the treatment of chronic neurological motor deficits secondary to traumatic brain injury (TBI). The designation is based on clinical results of SB623 including the Phase 2 Study of Modified Stem Cells in Traumatic Brain Injury (STEMTRA) trial.
Created under the 21st Century Cures Act, the RMAT designation is reserved for a regenerative medicine therapy intended to treat, modify, reverse, or cure a serious condition, and clinical evidence indicates that the therapy has the potential to address unmet medical needs for such disease or condition. Similar to the Breakthrough Therapy designation, the RMAT designation offers sponsors of cell and gene therapies eligibility for expedited development and regulatory review of their product candidate, including earlier and more frequent consultation with the FDA, and the potential for Priority Review and Accelerated Approval.
“The RMAT designation for SB623 is an important regulatory milestone for SanBio as we investigate it as a treatment option for patients with chronic neurological motor deficits resulting from a traumatic brain injury,” said Bijan Nejadnik, M.D., Chief Medical Officer and Head of Research. “TBIs are one of the most common health conditions worldwide that often cause long-term complications or death. We look forward to working with the FDA on a potentially accelerated clinical development program to address this serious unmet medical need.”