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Pioneering Phase 2 Imlifidase Study Reaches Enrollment Milestone in Fight Against Guillain-Barré Syndrome

Hansa Biopharma (Nasdaq Stockholm: HNSA), a leader in the development of innovative enzyme technology for rare immunological conditions, has successfully achieved full enrollment in its cutting-edge phase 2 clinical trial of imlifidase as a potential treatment for Guillain-Barré Syndrome (GBS). The trial’s top-line results are eagerly anticipated for release during the second half of 2023. Søren Tulstrup, Hansa Biopharma’s CEO and President, acknowledged the importance of this phase 2 study in unlocking the full potential of the company’s groundbreaking antibody-cleaving enzyme technology for treating rare immune disorders.

The ongoing phase 2 trial is an open-label, single-arm, multi-center study spanning the United Kingdom, France, and the Netherlands. The study is designed to explore the safety, tolerability, and effectiveness of imlifidase in combination with standard-of-care (SoC) intravenous immunoglobulin (IVIg) for GBS patients. Participants in the trial were given imlifidase before the administration of SoC treatment. After the database lock of the single-arm study, the efficacy parameters of patients treated with imlifidase and SoC will be juxtaposed with a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database, hosted at the Erasmus Medical Centre in Rotterdam, Netherlands. The findings of this comparative efficacy analysis are expected to emerge in 2024.

Professor Shahram Attarian, a prominent figure 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 nature of early diagnosis and treatment in managing GBS. Imlifidase, with its innovative approach to rapidly and effectively lowering IgG levels, could potentially revolutionize the way GBS patients are treated.

Guillain-Barré Syndrome is a rare, acute, paralyzing, and inflammatory disease that targets the peripheral nervous system, affecting 1-2 people per 100,000 annually. GBS is known for its rapid, progressive weakening of the limbs, leading to severe paralysis in the extremities. Under the current standard of care, about 25% of patients require extended 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.

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