Hansa Biopharma Reaches a Crucial Milestone in Imlifidase Phase 2 Clinical Trial for Guillain-Barré Syndrome
Hansa Biopharma (Nasdaq Stockholm: HNSA), a trailblazer in the world of enzyme technology aimed at rare immunological conditions, proudly announces that enrollment for its phase 2 clinical trial of imlifidase in Guillain-Barré Syndrome (GBS) has been successfully completed. The study’s top-line results are scheduled for release in late 2023. Søren Tulstrup, Hansa Biopharma’s CEO and President, highlighted the importance of this phase 2 study in deciphering the capabilities of the company’s pioneering antibody-cleaving enzyme technology for managing rare immunological disorders.
The multi-center, open-label, single-arm phase 2 trial is being conducted across the United Kingdom, France, and the Netherlands. The study aims to assess the safety, tolerability, and therapeutic potential of imlifidase when combined with standard-of-care (SoC) intravenous immunoglobulin (IVIg) for GBS patients. Trial participants received imlifidase before SoC treatment commenced. Following the database lock of the single-arm study, the efficacy data of patients treated with imlifidase and SoC will be contrasted against a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database, located at the Erasmus Medical Centre in Rotterdam, Netherlands. The outcome of this comparative efficacy analysis is projected to be available in 2024.
Professor Shahram Attarian, a distinguished authority in the Department of Neuromuscular Diseases and ALS at Hopitaux Universitaires de Marseille (APHM) and the International Coordinating Principal Investigator for the Phase 2 study, emphasizedthe importance of swift diagnosis and intervention in addressing GBS. Imlifidase, with its groundbreaking approach to rapidly and effectively reducing IgG levels, could potentially pave the way for a new paradigm in GBS treatment options.
Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory disease that impacts the peripheral nervous system, affecting 1-2 individuals per 100,000 people each year. GBS is characterized by its rapid, progressive weakening of the limbs, resulting in severe paralysis in the extremities. With the current standard of care, approximately 25% of patients require extended mechanical ventilation, and 20% remain unable to walk after six months. 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 the treatment of GBS