The SanBio Group (SanBio Co., Ltd. and subsidiary SanBio Inc.) (TOKYO:4592) has updated part of its March 13, 2018 release “Update on Development Progress of Regenerative Cell Medicine SB623”. Updated sections are underlined below.

In the SB623 development program targeting chronic motor deficit from ischemic stroke, a Phase 2b clinical trial jointly conducted with Sumitomo Dainippon Pharma Co., Ltd., is under way in the U.S., and enrollment of all 163 patients was completed in December 2017. The results of the trial are due in July 2019 following a 12-month follow-up period. In Japan, on February 14, 2018, SanBio and Teijin Limited terminated their licensing agreement, which previously had out-licensed to Teijin development and marketing of SB623 for stroke in Japan. Concurrently, SanBio initiated its own SB623 development program for chronic deficit from ischemic stroke in Japan with the objective to deliver a product in Japan earlier than in any other market in the world.

In a separate global development program targeting chronic motor deficit from traumatic brain injury (TBI), which SanBio is developing independently in Japan and the U.S., a Phase 2 clinical trial is under way, and patient enrollment has been completed with 61 patients enrolled versus the target of 52 patients. After a six-month follow-up period, SanBio plans to utilize the conditional and time-limited marketing authorization system for regenerative medicine products under the Revised Pharmaceutical Affairs Act of Japan to begin sales for its TBI indication before its other SB623 development programs. Specifically, SanBio plans to publish clinical trial results for its Phase 2 TBI study by the end of the fiscal year ending January 2019 and file for approval in the fiscal year ending January 2020.

 

Overview of development progress of SB623

Indication   Region   Progress to date   Schedule
Chronic motor deficit from ischemic stroke US, Canada Completed patient enrollment for Phase 2b, double-blind study (163 patients) in December 2017 Results to be published by July 2019 after 12-month follow-up period
Japan Terminated licensing agreement with Teijin in February 2018

Began preparations for starting own development program in February 2018.
Aim to deliver a product in Japan earlier than in any other market in the world.

Chronic motor deficit from traumatic brain injury   Global (US & Japan)  

Completed patient enrollment for Phase 2, double-blind study (61 patients) in April 2018

  

Results to be published in the fiscal year ending January 2019, after six-month follow-up period following completion of patient enrollment.

(Japan) Aim to file for approval in the fiscal year ending January 2020 assuming utilization of Japan’s conditional and time-limited marketing authorization system for commercialization.