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SanBio Group announced positive results from the one-year analysis of its Phase 2 STEMTRA trial evaluating SB623 for chronic motor deficits from traumatic brain injury (TBI). The study met its primary endpoint, showing significant improvements in motor function and daily living activities compared to sham surgery. Results will be presented at the American Academy of Neurology Annual Meeting on April 5, 2022. SB623, a regenerative cell treatment, has received Sakigake and orphan designations in Japan, with plans for a Phase 3 trial in the U.S.
SanBio Group has submitted an application to Japan's Ministry of Health for marketing approval of SB623, a regenerative medicine product aimed at treating chronic motor deficits from traumatic brain injury (TBI). This follows positive results from the Phase 2 STEMTRA trial, where SB623 demonstrated significant motor function improvement compared to sham surgery. The product has received priority review and orphan designation from Japanese authorities and RMAT designation from the FDA, highlighting its potential to address a critical medical need.
SanBio Group (OTC-PINK:SNBOY) has joined the National TBI Registry Coalition (NTRC) as a founding member. Launched on December 6, 2021, the NTRC aims to create a national registry for individuals with traumatic brain injury (TBI), enhancing surveillance and awareness. SanBio is preparing to file a Biologics License Application in Japan for its lead product, SB623, which targets chronic motor deficits from TBI. TBI affects millions globally, with significant long-term disabilities reported, highlighting the need for effective treatment and support.
SanBio Company Limited (SNBOY) announced a partnership with D&P Bioinnovations, Inc. for developing a regenerative esophageal implant using its MSC2 technology on November 15, 2021. SanBio grants D&P a non-exclusive license to MSC2, receiving commercialization rights in Japan and first negotiation rights in Asia. The company will earn tiered royalties up to 2.5% from D&P's sales outside Japan and up to 20% from profits if D&P out-licenses the implant. While immediate fiscal impact is minimal, SanBio anticipates medium to long-term benefits from this collaboration.
SanBio Group has published significant data in Expert Review of Neurotherapeutics, focusing on outcome measures for chronic motor deficits in traumatic brain injury (TBI). The study introduces minimally clinically important differences (MCIDs) for the Disability Rating Scale (DRS) and Fugl-Meyer Motor Scale (FMMS), essential for future clinical trials. With findings derived from the 61 patient STEMTRA trial, results showed that SB623 led to an average 8.3-point improvement in FMMS compared to 2.3 points in the control group. The company aims to file for regulatory approval for SB623 as a regenerative medicine.
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