Hansa Biopharma Showcases Imlifidase's Promise in Guillain-Barré Syndrome at 2025 PNS Meeting
Hansa Biopharma Reveals Imlifidase Research Findings at 2025 PNS Annual Meeting
Hansa Biopharma, a biopharmaceutical leader, is poised to make headlines at the upcoming 2025 Peripheral Nerve Society (PNS) Annual Meeting in Edinburgh, Scotland, from May 17-20. The company plans to present key findings from their pivotal Phase 2 clinical trial, known as 15-HMedIdeS-09, exploring the efficacy of imlifidase, a novel IgG-cleaving enzyme, in patients diagnosed with Guillain-Barré Syndrome (GBS).
The research, initially shared in December 2024, reveals significant insights about the potential of imlifidase in redefining treatment protocols for GBS, a rare condition typically characterized by rapid muscle weakness and paralysis. Professor Shahram Attarian, an esteemed clinical investigator from the Hopitaux Universitaires de Marseille, will share the study outcomes, underscoring the clinical relevance of this innovative therapy.
Important Insights from the 15-HMedIdeS-09 Study
The Phase 2 study was a single-arm, open-label trial conducted across multiple centers in the UK, France, and the Netherlands. It focused on a specific patient demographic: 30 adult GBS patients who received a single dose of imlifidase at a dosage of 0.25 mg/kg, alongside the standard of care treatment with intravenous immunoglobulin (IVIg). The preliminary results indicate that treatment with imlifidase was both safe and tolerated well among participants.
"We are excited to provide further details on our Phase 2 study outcomes, which indicate that imlifidase may significantly enhance the treatment landscape for GBS patients, particularly when used in conjunction with established therapies like IVIg," said Hitto Kaufmann, Chief Research and Development Officer at Hansa Biopharma.
The study's outcomes suggest that IgG plays a critical role in driving inflammatory responses that affect peripheral nerves, fundamentally linked to the severity and progression of GBS. Given that current treatment options often lag in effectiveness, the urgency for novel therapies that can expedite patient recovery has never been clearer.
Understanding Guillain-Barré Syndrome
Guillain-Barré Syndrome is an acute inflammatory disorder of the peripheral nervous system, where the immune system can mistakenly disrupt nerve cell function. An estimated annual incidence ranges from 1 to 2 cases per 100,000 individuals, leading to muscle weakness that can progress to paralysis. Approximately one in four patients may require mechanical ventilation to assist with breathing, while many experience lasting mobility issues.
The data generated through Hansa's Phase 2 study will likely offer compelling insights that could reshape treatment protocols for this severe condition and improve the quality of care provided to affected individuals.
The Broader Perspective on Imlifidase
Imlifidase is defined by its unique ability to cleave IgG antibodies, effectively neutralizing their activity within hours of administration. Aside from its prospective use in GBS, it has already received conditional marketing approval in Europe under the trade name IDEFIRIX®, primarily to aid highly sensitized adult kidney transplant patients.
Hansa Biopharma is committed to leveraging this groundbreaking IgG-cleaving technology to manage several autoimmune disorders, with ongoing studies targeting conditions like anti-GBM disease, myasthenia gravis, and more.
As the biopharmaceutical company continues to innovate and explore new therapeutic avenues, the upcoming PNS Annual Meeting will serve as a prominent platform for Hansa Biopharma to showcase the transformative potential of imlifidase in the fight against debilitating autoimmune diseases like Guillain-Barré Syndrome.