Hansa Biopharma, "Hansa" 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. Even with current standard of care - either plasma exchange or immunoglobin therapy - GBS is fatal in 3-7% of cases. 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.

All subjects received a full dose of imlifidase, and no serious adverse events caused by imlifidase infusion related reactions were recorded. Autoimmune diseases form a group of serious diseases caused by the immune system attacking the body. In many autoimmune diseases the immune system mistakenly recognizes the body's own proteins as foreign and mounts an immune response, creating antibodies to attack the body's own cells and tissues.

Pathogenic IgG can contribute to a broad spectrum of autoimmune diseases. Hansa is exploring how imlifidase may be able to prevent or slow the progression of these diseases and their debilitating, life-threatening symptoms. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease, Guillain-Barre Syndrome, and ANCA-associated vasculitis. In 2018, the U.S. Food and Drug Administration granted Orphan Drug Designation to imlifidase for the treatment of GBS.

Despite treatment with current standard of care, GBS has a serious long-term impact on the patients' work and private life, even 3-6 years after the onset of illness. Recovery can be slow and take years. Persistent disability is seen in 20%-30% of adult patients and severe fatigue is a sequel of GBS in two thirds of adult patients.