The trial has been designed to assess imlifidase in combination with SoC intravenous immunoglobulin while treating GBS patients. Credit: fernandozhiminaicela from Pixabay.

Hansa Biopharma has concluded enrolling patients in its Phase ll trial of imlifidase for the treatment of Guillain-Barré Syndrome (GBS).

GBS, which is a rare, acute, paralysing, inflammatory disease of the peripheral nervous system, is estimated to impact one to two individuals in 100,000 people per year.

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The Phase ll open label, single arm, multi-centre study is being carried out across the UK, France, and the Netherlands.

It has been designed to assess the safety, tolerability and efficacy of imlifidase in combination with standard of care (SoC) intravenous immunoglobulin (IVIg) while treating GBS patients.

Patients participating in the trial have received imlifidase before SoC.

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Hansa Biopharma plans to provide top line data from the study in the second half of this year.

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After the completion of the database lock of the single arm trial, efficacy of patients treated with imlifidase and SoC will be compared with an external matched cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database.

This comparative efficacy analysis will be conducted at the Erasmus Medical Centre in Rotterdam, Netherlands, with results being anticipated next year.

Hansa Biopharma president and CEO Søren Tulstrup said: “This Phase ll study of imlifidase in GBS is an important next step in understanding the role of our antibody-cleaving enzyme technology in treating rare immunologic conditions.

“We remain fully committed to advancing the science and delivering innovative therapies to the many patients affected by severe immunologic conditions.”