Swedish biopharmaceutical company Hansa Biopharma (STO:HNSA) on Tuesday announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barre Syndrome (GBS), a rare neurological disease.

The company also reported findings of an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barre Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS.

Data from the 15-HMedIdeS-09 study demonstrated that severe GBS patients treated with a single dose of imlifidase (0.25 mg/kg) plus intravenous immunoglobulin (IVIg) had rapid overall improvement in functional status including expedited recovery of muscle strength, fast return to independently walking, and a median time to independently walk (e.g., reaching Guillain-Barré Syndrome Disability Scale (GBS DS) 2 or less) by 16 days.

The indirect treatment comparison concluded that patients in the 15-HMedIdeS-09 study treated with imlifidase plus IVIg returned to independently walking 6 weeks sooner when compared to severe GBS patients in the IGOS real-world comparator group treated with IVIg. Additionally, patients in the 15-HMedIdeS-09 study experienced statistically significant improvement across several clinically meaningful measures at multiple time points as compared to the IGOS real-world comparator group including 6.4 times more likely at week 1, and 4.2 times more likely at week 4 to walk independently.

The 15-HMedIdeS-09 study included 30 adult patients who were treated with imlifidase plus IVIg. During the study, three patients were re-diagnosed, and the remaining 27 patients received a confirmatory diagnosis of severe GBS and were included in the efficacy analysis.

Hitto Kaufmann, Hansa Biopharma chief R&D officer, said: "Unlike other molecules, imlifidase can effectively and very rapidly remove IgG through enzymatic cleavage -- halting the progression of nerve damage associated with GBS and stopping disease progression. The main goal of improved GBS treatments is to stop nerve damage early, reducing the time of hospitalisation and support patients in regaining independence sooner. These findings underscore the role pathogenic IgG plays in severity and progression of GBS, and the clear potential of imlifidase to address unmet need in IgG-driven autoimmune diseases where faster acting treatment options are needed."