Therapy Areas: Central Nervous System
BioArctic's interim analysis of phase 1/2 study of SC0806 in patients with CSC injury halts spinal cord injury project
19 November 2019 -

BioArctic AB (STO: BIOAB), a Swedish research-based biopharmaceutical company, reported on Monday the results of an interim analysis of a phase 1/2 study of SC0806 in patients with complete spinal cord injury.

Under 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. This means that the study did not meet the primary efficacy endpoint. Also, 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 programme.

BioArtic clarified that these decisions do not impact its research and development of novel drugs targeting Alzheimer's, Parkinson's and other diseases in the central nervous system.

BioArctic's treatment concept, 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 fibres across the injured area in the spinal cord. Preclinical studies with SC0806 showed nerve regeneration, restored electrophysiology and improved motor function. These groundbreaking preclinical results were the basis for the decision by the company to start a clinical phase 1/2 study of SC0806 in patients with complete spinal cord injury.

These study results are planned to be submitted for publication in a scientific journal at a later date. This phase 1/2 clinical study has received funding from the European Union's Horizon2020 Research and Innovation Program under Grant Agreement No. 643853.

BioArctic is focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease.