Hansa Biopharma AB, will present data from its 15-HMedIdeS-09 Phase 2 single arm study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barre Syndrome (GBS) at the Peripheral Nerve Society (PNS) Annual Meeting, taking place 17-20 May in Edinburgh, Scotland. Hansa communicated the results from the 15-HMedIdeS -09 study in December 2024. Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de Marseille (APHM) and International Coordinating Principal Investigator will present data from 15-HMedIde S-09 Phase 2 study at the 2025 PNS Annual Meeting.
Hansa's Phase 2 15-HMedIdes-09 open-label, single arm study was performed across multi-centers in the UK, France, and the Netherlands evaluating the safety, tolerability, and efficacy of a single dose of imlifidase (0.25 mg/kg) in 30 adult GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg). The administration of imlifidase prior to SoC in patients with GBS was considered to be safe and well tolerated. Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.
It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name IDEFIRIX®? for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
