Bioarctic announced results from an interim analysis of a Phase 1/2 study of SC0806 in patients with complete spinal cord injury. In this analysis, none of the patients showed an effect as measured by electrical impulses passing through the injured area after treatment. Electrical impulse passage is considered a prerequisite to restore motor function. As a result, the study did not meet the primary efficacy endpoint. In addition, the results did not show convincing efficacy on secondary endpoints regarding motor function, other functions or quality of life. Based on these results BioArctic has decided to stop the inclusion of patients in the ongoing Phase 1/2 study. The company has also decided not to further develop the complete spinal cord injury project after the final patient has completed the training program.
The Phase 1/2 study was designed to include three panels with nine patients in each, with six patients receiving SC0806 and three control patients. Patients treated with SC0806 received the implant through a surgical procedure followed by at least 18 months of intensive training in a robotic system to support nerve regeneration and rebuilding of muscle affected by the paralysis. Control patients received training only. Safety and tolerability of the treatment have been measured in the study. The primary efficacy endpoint was measured by MEP (Motor Evoked Potential) that shows the occurrence of electrical impulses passing through the injured area. Secondary efficacy endpoints include sensory and motor function as measured by AIS (American Spinal Injury Association Impairment Scale), other physical function measures and clinician and self-assessed parameters.
The study results are planned to be submitted for publication in a scientific journal at a future date.
SC0806 is a biodegradable medical device surgically implanted into the injured spinal cord with the goal to restore function. The implant contains the growth factor FGF1 and is designed to support nerve regeneration. The channels in the implanted device guide nerve fibers across the injured area in the spinal cord. Preclinical studies with SC0806 showed nerve regeneration, restored electrophysiology and improved motor function.