Hansa Biopharma (Nasdaq Stockholm: HNSA), an enzyme technology pioneer focused on transforming the lives of those with rare immunological disorders, proudly announces the completion of enrollment in its groundbreaking phase 2 clinical trial for imlifidase in Guillain-Barré Syndrome (GBS). The top-line findings from this study are slated for release in late 2023. Søren Tulstrup, the CEO and President of Hansa Biopharma, emphasized the trial’s significance in unraveling the potential of the company’s unique antibody-cleaving enzyme technology in tackling rare immune-mediated diseases.
The phase 2 trial, a collaborative effort across the United Kingdom, France, and the Netherlands, is an open-label, single-arm, multi-center study. It aims to evaluate the safety, tolerability, and therapeutic potential of imlifidase in conjunction with standard-of-care (SoC) intravenous immunoglobulin (IVIg) for GBS patients. Trial participants received imlifidase prior to SoC treatment. Upon database lock of the single-arm study, the efficacy data of patients treated with both imlifidase and SoC will be contrasted against a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database, housed 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 key figure in the Department of Neuromuscular Diseases and ALS at Hopitaux Universitaires de Marseille (APHM) and the International Coordinating Principal Investigator in the Phase 2 study, highlighted the crucial role of timely diagnosis and intervention in GBS treatment. Imlifidase, by rapidly and effectively reducing IgG levels, represents a potentially game-changing approach for GBS patients.
Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory peripheral nervous system disorder that affects 1-2 individuals per 100,000 people annually. GBS is characterized by rapid, progressive limb weakness and can lead to severe paralysis. With current standard care, approximately 25% of patients need long-term mechanical ventilation, and 20% remain unable to walk after six months. GBS has a fatality rate of 3-7%. In 2018, the US Food and Drug Administration granted Orphan Drug Designation to imlifidase for GBS treatment.