The status was provided based on clinical results of SB623, including the phase 2 study of modified stem cells in traumatic brain injury (STEMTRA) trial.
SB623 is a cell-based investigational product produced using modified and cultured adult bone marrow-derived mesenchymal stem cells, which undergo temporary genetic modification.
Implantation of SB623 cells into injured nerve tissue in the brain is expected to enhance the natural regenerative capacity of the brain to recover lost motor functions.
STEMTRA was a one-year, randomised, double-blind, surgical sham-controlled and global trial, which assessed the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to TBI.
The SB623 cells have been implanted directly around the site of brain injury in this study.
According to the company, the SB623 achieved its primary endpoint, with patients treated with SB623 reaching an average 8.3 point improvement from baseline in the FMMS, against 2.3 in the control group, at 24 weeks.
The company is planning to commence a phase 3 trial for SB623 to treat chronic neurological motor deficits secondary to TBI by the end of the fiscal year ending on 31 January 2021.
At present, the company is conducting a phase 2b clinical trial to treat chronic motor deficit resulting from ischemic stroke.
SanBio chief medical officer and research head Dr Bijan Nejadnik said: “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.
“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.”
SanBio Group is a regenerative medicine company, which is involved in the development of cell-based products to treat neurological disorders.
In September 2014, Sumitomo Dainippon Pharma entered into a joint development and licence agreement with SanBio for exclusive marketing rights in the US and Canada for SB623, a cell therapy to treat patients with chronic stroke.