Swedish company BioArctic has secured approval from the Estonian State Agency of Medicines, the Estonian Health Board for medical device, and the local ethics committee to include Estonian patients in the ongoing studies of SC0806 for spinal cord injury.
A combination of a medical device (implant) and a medicinal product (FGF1), the product candidate SC0806 is currently under development and undergoing Phase 1/2 clinical trials.
It is designed to support nerve regeneration across the injured area in the spinal cord.
The Estonian patients will be treated with SC0806 at the Karolinska University Hospital in Stockholm, Sweden.
It would be followed by an 18-month training period to improve all the treated patients’ motor ability in the paralysed part of the body.
The initial rehabilitation will be carried out in Sweden and it will then continue in Estonia.
BioArctic CEO Gunilla Osswald said: “It is important to develop a treatment for these patients since there is no effective medical treatment available today.
“Our ambition is to develop SC0806 to improve the quality of life for patients with complete spinal cord injury.”
In 2010, the product received orphan drug designation in EU followed by the US in 2011. This designation gives BioArctic ten years and seven years of market exclusivity in Europe and the US respectively.
To conduct this clinical study, the company has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement No 643853.