Hansa Biopharma AB (Hansa)(STO: HNSA), a provider of immunomodulatory enzyme technology for rare IgG-mediated diseases, announced on Monday the receipt of Clinical Trial Application and Ethics Committee approvals in Europe for the company's phase 2 study of imlifidase in Guillain Barré Syndrome (GBS).

GBS is a rare, acute, paralysing, inflammatory disease of the peripheral nervous system that affects one to two in 100,000 people annually. GBS is an aggressive neurological disease, with many patients deteriorating despite standard of care treatment. Two thirds of GBS patients have severe symptoms resulting in their inability to walk unaided and 20-30% require mechanical ventilation for weeks or months.

Reportedly, in 2018, the US Food and Drug Administration had granted Orphan Drug Designation to imlifidase for the treatment of GBS.

This study will enrol up to 30 patients at approximately ten clinics in France, UK and the Netherlands over the next 18 months. The study is an open-label, single arm, multi-centre study evaluating the safety, tolerability and efficacy of imlifidase in GBS patients in combination with standard of care intravenous immunoglobulin (IVIg).

The 30 GBS patients enrolled in the study will be compared to a matched control group of GBS patients treated with IVIg from the International Guillain-Barré Syndrome Outcome Study (IGOS) database.

All subjects in Hansa's study will receive a single, 30-minute infusion of imlifidase as soon as possible after diagnosis, followed by standard of care IVIg treatment two days later. Safety and efficacy, primarily measured as improvement on the GBS functional scale, will be monitored over a 12-month period post treatment, with an initial end point read out at six months.