The phase 2 recruitment for Hansa Biopharma’s imlifidase research in Guillain-Barré syndrome has been completed, according to the company, a pioneer in enzyme technology for uncommon immunological disorders (GBS). The second half of 2023 is anticipated to see the release of top-line figures. “Our phase 2 research of imlifidase in GBS is a critical next step in understanding the significance of our antibody-cleaving enzyme technology in treating rare immunologic disorders,” said Sren Tulstrup, president and chief executive officer of Hansa Biopharma. We continue to be wholly dedicated to developing science and providing cutting-edge treatments to the numerous people suffering from serious immunologic disorders.
The open-label, single-arm phase 2 GBS trial is being conducted in the UK, France, and the Netherlands and examines the safety, tolerability, and effectiveness of imlifidase when used in conjunction with intravenous immunoglobulin (SoC) in GBS patients (IVIg). Imlifidase was administered to enrolled participants before to SoC. After the single arm study’s database has been locked, a matched external cohort from the International Guillain-Barré Syndrome Outcome Study (IGOS) database at the Erasmus Medical Centre in Rotterdam, the Netherlands, will be used to compare efficacy parameters from patients treated with imlifidase and SoC. It is anticipated that the results of the comparative efficacy analysis between the two cohorts would be shared in 2024.
“In the treatment of GBS, a timely diagnosis and treatment are crucial to reducing the severity of the symptoms and minimising long-term damage,” said Professor Shahram Attarian, head of the department of neuromuscular diseases and ALS at Hopitaux Universitaires de Marseille (APHM) and the international coordinating principal investigator in the phase 2 study. Imlifidase is a novel therapy option for GBS patients with a special method aimed at swiftly and successfully lowering IgG levels.
One to two people per 100,000 are affected each year by GBS, an uncommon, acute, paralysing, inflammatory disease of the peripheral nerve system. It is a violent neurological condition that weakens the extremities quickly and gradually. Around 25% of patients require artificial ventilation for weeks or months, and 20% are unable to walk after six months due to the severe paresis that can develop in the arms and legs. GBS is deadly in 3-7% of cases with the current level of care.
Imlifidase’s use as an orphan drug to treat GBS was approved by the US Food and Drug Administration in 2018. The goal of Hansa Biopharma, a cutting-edge commercial-stage biopharmaceutical firm, is to create and market novel, life-changing, and life-saving therapies for people with uncommon immunological disorders.
