Hansa Biopharma (Nasdaq Stockholm: HNSA), a pioneer in developing enzyme technology for the treatment of rare immunological disorders, is thrilled to report the successful completion of enrollment in its innovative phase 2 clinical trial exploring the potential of imlifidase for Guillain-Barré Syndrome (GBS). The top-line findings of this groundbreaking study are anticipated to be released in the latter half of 2023. Søren Tulstrup, CEO and President of Hansa Biopharma, emphasized the importance of this clinical trial in showcasing the potential of the company’s unique antibody-cleaving enzyme technology to treat rare immunological conditions.
This phase 2 trial, a multi-center, open-label, single-arm study, is being carried out in the United Kingdom, France, and the Netherlands. It aims to evaluate the safety, tolerability, and efficacy of imlifidase when combined with standard-of-care (SoC) intravenous immunoglobulin (IVIg) for GBS patients. Participants in the trial received imlifidase before starting SoC treatment. Following the database lock of the single-arm study, the efficacy outcomes will be compared to a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database at the Erasmus Medical Centre in Rotterdam, Netherlands. The comparative efficacy analysis results are expected to be announced in 2024.
Professor Shahram Attarian, a leading expert 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, highlighted the critical importance of timely diagnosis and treatment in the management of GBS. By focusing on rapidly and effectively reducing IgG levels, imlifidase could offer a game-changing treatment approach for GBS patients.
Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory disorder that affects the peripheral nervous system, with an incidence of 1-2 cases per 100,000 people annually. GBS causes rapid and progressive weakness in the limbs, potentially resulting in severe paralysis. Under current standard of care, approximately 25% of patients require long-term 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 GBS treatment.
