Hansa Biopharma (Nasdaq Stockholm: HNSA), a vanguard in the field of enzyme technology for the treatment of rare immunological diseases, proudly announces the completion of patient enrollment in its trailblazing phase 2 clinical study of imlifidase for Guillain-Barré Syndrome (GBS). The top-line data derived from this study is expected to be unveiled in late 2023. Søren Tulstrup, CEO and President of Hansa Biopharma, stressed the crucial role of this trial in uncovering the therapeutic potential of the company’s proprietary antibody-cleaving enzyme technology for managing rare immunological disorders.
The phase 2 study, conducted across the United Kingdom, France, and the Netherlands, is an open-label, single-arm, multi-center trial. It is designed to assess the safety, tolerability, and efficacy of imlifidase when used in conjunction with standard-of-care (SoC) intravenous immunoglobulin (IVIg) in GBS patients. Trial participants received imlifidase before the initiation of SoC treatment. After locking the database of the single-arm study, the efficacy outcomes 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 results of this comparative efficacy analysis are anticipated to be disclosed in 2024.
Professor Shahram Attarian, a leading 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, highlighted the importance of timely diagnosis and treatment in addressing GBS. Imlifidase, with its pioneering approach to rapidly and effectively reducing IgG levels, could potentially usher in a new era of treatment options for GBS patients.
Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory disease that affects the peripheral nervous system, with an incidence rate of 1-2 cases per 100,000 people annually. GBS is characterized by the rapid, progressive weakening of the limbs, resulting in severe paralysis. With the current standard of care, approximately 25% of patients require prolonged mechanical ventilation, and 20% remain unable to walk after six months. GBS has a fatality rate of 3-7% under standard care. In 2018, the US Food and Drug Administration granted Orphan Drug Designation to imlifidase for GBS treatment.