BioArctic AB has been granted a U.S. patent for a method with a medical device to treat patients with complete spinal cord injury.

The patent protection is in line with the company’s strategy to protect important products through patents. A corresponding patent has previously been granted in China and recently in Australia for product SC0806.
 
SC0806 is a novel product under development for the treatment for patients with complete spinal cord injury. The product candidate is currently in an ongoing Phase 1/2 clinical trial. The first patient was treated in 2016 at Karolinska University Hospital in Sweden. The product candidate is a combination of a biodegradable medical device and a drug substance (FGF1) designed to support nerve regeneration across the injured area in the spinal cord. The product obtained orphan drug designation in 2010 in the European Union and in 2011 in the United States, which gives the company 10 and seven years of market exclusivity in Europe and the United States, respectively.

BioArctic's potential regenerative treatment concept consists of a biodegradable device with an adjunctive drug Fibroblast Growth Factor 1 (FGF1) that stiumulates nerve regeneration and reduces scar formation. The project is inlicensed from Swenora Biotech AB and is based on research at Karolinska Institutet and Karolinska University Hospital.

The treatment includes a surgical procedure in which a degradable implant containing peripheral nerves and growth factor FGF1 are operated into the damaged spinal cord to cause nerve regeneration (overgrowth) of nerve pathways over the area of injury. The device supports the guiding and regeneration of nerves and provides high anatomical precision in the surgical procedure, which aims at functional improvement of significant medical importance. The surgery is then followed by 18 months of rehabilitation.
 
BioArctic has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement No. 643853 to perform a clinical study with SC0806.
 
A spinal cord injury occurs when trauma or disease damages the spinal cord and results in partial or complete paralysis. The incidence ranges between 12.7 and 44.3 per million inhabitants depending on country.¹ Some 40 percent of these patients are estimated to have chronic complete spinal cord injury.² Patients with complete spinal cord injury require lifelong therapy and care, which means high costs for the healthcare system. The victims are usually young people. The injury has little effect on life expectancy, but leads to major challenges to maintain an acceptable quality of life. Following complete injury, the patient faces a permanent loss of function below the site of injury, with devastating consequences for the patient’s quality of life. Today there is no effective treatment available for the patients.

BioArctic AB is a Swedish research based biopharmaceutical company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a potential treatment for complete spinal cord injury. BioArctic focuses on treatments in areas with high unmet medical needs. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and in-house projects with significant market and out-licensing potential. BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap.

References
1. Datamonitor, Stakeholder Opinions: Spinal Cord Injury, 2010.
2. NSCISC Annual Statistics report 2010.