Hansa Biopharma, “Hansa”, today announced positive high-level data from the 15-HMedIdeS-09 phase 2 trial that demonstrated imlifidase was safe and well tolerated when administered prior to standard of care, including rapid improvement in disease-related efficacy measures. Further analysis of efficacy data will be conducted in 2024. 15-HMedIdeS-09 is an open-label, single arm, trial evaluating the safety, tolerability and efficacy of imlifidase in GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg).
GBS is a rare, acute, paralyzing, inflammatory disease of the peripheral nervous system caused by the immune system damaging nerve cells and structures. It affects 1-2 in 100,000 people annually. In GBS, rapid onset and progression of muscle weakness occurs and can lead to severe paralysis of the arms and legs. Approximately 25% of patients require mechanical ventilation for days to months and 20% are unable to walk after six months.2,3 Even with current standard of care - either plasma exchange or immunoglobin therapy - GBS is fatal in 3-7% of cases.
The results of 15-HMedIdeS-09 are very encouraging. Imlifidase was safe and well tolerated, and when compared to previously published data, a rapid improvement across several efficacy outcome measures was observed in patients treated with imlifidase in combination with standard of care. Immunoglobulin G (IgG) antibodies are thought to play an important role in GBS disease. With its ability to rapidly cleave IgGs, imlifidase could be a promising new option for halting this progressive and oftentimes debilitating disease.”
Dr. Achim Kaufhold, Chief Medical Officer, Hansa Biopharma
Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de Marseille (APHM), and International Coordinating Principal Investigator in the Phase 2 trial, said, “In the treatment of GBS, reducing the long-term damage caused to the peripheral nervous system is key. In severe patients, this damage can lead to long recovery times or even permanent muscle weakness, pain, and fatigue. The immediate reduction of autoantibodies could help stop the progression of the disease. I look forward to seeing the full results of this trial to better understand how imlifidase may be able to help more rapidly stop and revert the progression of GBS.”
Further analysis will contextualize efficacy data from the single arm 15-HMedIdeS-09 study through a comparison to data from patients receiving standard of care treatment in the International Guillain-Barré Syndrome Outcome Study (IGOS) database. This analysis is expected to be completed and communicated in 2024.
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