DISAPPOINTING: Swedish company's clinical trials for a cure discontinued due to lack of success

FGF1, a growth factor involved in neural regeneration and healing

We had previously reported about Swedish company, BioArctic, which announced a year ago the launch of their Phase I/II clinical trials for those with a complete spinal cord injury that used a biodegradable medical device in tandem with a drug to support nerve regeneration across the injured area of the spinal cord. Unfortunately, the company announced last week that none of the patients enrolled in the study showed any 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. 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 decided not to further develop the complete spinal cord injury project after the final patient has completed the training program.

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 fibers 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.