Hansa Biopharma (Nasdaq Stockholm: HNSA), a trailblazer in enzyme technology targeting rare immunological disorders, has successfully finalized patient enrollment in the phase 2 clinical trial for imlifidase as a potential treatment for Guillain-Barré Syndrome (GBS). The top-line results are anticipated to be revealed in the latter half of 2023. CEO and President of Hansa Biopharma, Søren Tulstrup, expressed that the current study is an essential advancement in understanding the efficacy of the company’s innovative antibody-cleaving enzyme technology for rare immunological diseases.
The ongoing phase 2 trial is an open-label, single-arm, multi-center study being conducted across the United Kingdom, France, and the Netherlands. It is designed to assess the safety, tolerability, and effectiveness of imlifidase combined with standard-of-care (SoC) intravenous immunoglobulin (IVIg) in GBS patients. Participants have received imlifidase prior to SoC administration. After the database lock of the single-arm study, the efficacy parameters of patients treated with both imlifidase and SoC will be compared with a corresponding external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database maintained at the Erasmus Medical Centre in Rotterdam, Netherlands. The comparative efficacy analysis results between these cohorts are expected to be available in 2024.
Professor Shahram Attarian, Head of the Department of Neuromuscular Diseases and ALS at Hopitaux Universitaires de Marseille (APHM) and the International Coordinating Principal Investigator in the Phase 2 study, emphasized the importance of prompt diagnosis and treatment in GBS. Imlifidase offers a novel approach to treatment by rapidly and effectively reducing IgG levels, potentially benefiting GBS patients.
Guillain-Barré Syndrome is a rare, acute, paralyzing, inflammatory disorder affecting the peripheral nervous system, with an annual incidence of 1-2 cases per 100,000 people. GBS is a rapidly progressing neurological disease that weakens the limbs and can lead to severe paralysis. Approximately 25% of patients need mechanical ventilation for extended periods, and 20% are unable to walk after six months. Currently, GBS has a fatality rate of 3-7% with standard care. In 2018, the US Food and Drug Administration granted Orphan Drug Designation to imlifidase for GBS treatment.