Hansa Biopharma (Nasdaq Stockholm: HNSA), an innovative frontrunner in enzyme technology dedicated to addressing rare immunological disorders, is pleased to announce the completion of patient enrollment in its novel phase 2 clinical trial exploring imlifidase as a treatment for Guillain-Barré Syndrome (GBS). The trial’s top-line results are eagerly awaited and slated for release in the latter half of 2023. Hansa Biopharma’s CEO and President, Søren Tulstrup, emphasized the trial’s significance in revealing the potential of the company’s cutting-edge antibody-cleaving enzyme technology for treating rare immune-mediated diseases.
The ongoing phase 2 trial spans the United Kingdom, France, and the Netherlands and is an open-label, single-arm, multi-center study. Its purpose is to examine the safety, tolerability, and effectiveness of imlifidase when used alongside standard-of-care (SoC) intravenous immunoglobulin (IVIg) in GBS patients. Enrolled participants were given imlifidase prior to the initiation of SoC treatment. After the database lock of the single-arm study, the efficacy outcomes of patients treated with imlifidase and SoC will be compared with a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database, based at the Erasmus Medical Centre in Rotterdam, Netherlands. The findings of this comparative efficacy analysis are expected to be revealed in 2024.
Professor Shahram Attarian, a renowned 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, emphasized the critical role of prompt diagnosis and intervention in managing GBS. By quickly and effectively lowering IgG levels, imlifidase could potentially introduce a novel therapeutic approach for GBS patients.
Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory condition affecting the peripheral nervous system, with an annual incidence rate of 1-2 cases per 100,000 people. GBS is known for its aggressive neurological effects, causing rapid and progressive weakness in the extremities and potentially leading to severe paralysis. Under the current standard of care, about 25% of patients require long-term mechanical ventilation, and 20% continue to be 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 awarded Orphan Drug Designation to imlifidase for the treatment of GBS.