Immunomodulatory technology company Hansa Biopharma AB (NASDAQ Stockholm:HNSA) reported on Friday the receipt of the Clinical Trial Application and Ethics Committee approvals in Europe for the launch of its Phase 2 study of imlifidase in Guillain Barré Syndrome (GBS), a rare, acute, paralysing, inflammatory disease of the peripheral nervous system.
Imlifidase is an enzyme that specifically cleaves immunoglobulin G (IgG) antibodies, inhibiting the IgG-mediated immune response, revealed the company.
The study, which will enrol up to 30 patients at approximately ten clinics in France, UK and the Netherlands over the next 18 months, 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).
As part of the study, the 30 GBS patients will be compared to a matched control group of GBS patients treated with IVIg from the International Guillain-Barré Syndrome Outcome Study (IGOS) database, disclosed the company.
All subjects in 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. The 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, the company added.
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