Hansa Biopharma data at the 2025 PNS Annual Meeting demonstrates potential of imlifidase in the treatment of GBS
Hansa Biopharma (HNSA) will present data from its Phase 2 single-arm study of imlifidase, an IgG cleaving enzyme, for treating Guillain-Barré Syndrome (GBS) at the 2025 PNS Annual Meeting in Edinburgh. The study, conducted across the UK, France, and Netherlands, evaluated a single dose of imlifidase (0.25 mg/kg) combined with standard of care intravenous immunoglobulin (IVIg) in 30 adult GBS patients.
Professor Shahram Attarian from Hopitaux Universitaires de Marseille will present the findings on May 18. The study results, initially communicated in December 2024, showed that administering imlifidase prior to standard of care was safe and well-tolerated, demonstrating significant potential for treating GBS patients.
Hansa Biopharma (HNSA) presenterà i dati del suo studio di Fase 2 a braccio singolo sull'imlifidase, un enzima che taglia le IgG, per il trattamento della Sindrome di Guillain-Barré (GBS) al Congresso Annuale PNS 2025 a Edimburgo. Lo studio, condotto nel Regno Unito, Francia e Paesi Bassi, ha valutato una singola dose di imlifidase (0,25 mg/kg) in combinazione con la terapia standard a base di immunoglobuline endovenose (IVIg) in 30 pazienti adulti con GBS.
Il Professor Shahram Attarian degli Hopitaux Universitaires de Marseille presenterà i risultati il 18 maggio. I dati dello studio, comunicati inizialmente a dicembre 2024, hanno mostrato che somministrare l'imlifidase prima della terapia standard era sicuro e ben tollerato, dimostrando un significativo potenziale nel trattamento dei pazienti con GBS.
Hansa Biopharma (HNSA) presentará datos de su estudio de fase 2 de brazo único sobre imlifidasa, una enzima que corta IgG, para el tratamiento del Síndrome de Guillain-Barré (GBS) en la Reunión Anual PNS 2025 en Edimburgo. El estudio, realizado en Reino Unido, Francia y Países Bajos, evaluó una dosis única de imlifidasa (0,25 mg/kg) combinada con el tratamiento estándar de inmunoglobulina intravenosa (IVIg) en 30 pacientes adultos con GBS.
El profesor Shahram Attarian de los Hopitaux Universitaires de Marseille presentará los hallazgos el 18 de mayo. Los resultados del estudio, comunicados inicialmente en diciembre de 2024, mostraron que administrar imlifidasa antes del tratamiento estándar fue seguro y bien tolerado, demostrando un potencial significativo para tratar a pacientes con GBS.
한사 바이오파마(HNSA)는 2025년 에든버러에서 열리는 PNS 연례회의에서 이믈리피다제라는 IgG 절단 효소를 이용한 길랭-바레 증후군(GBS) 치료를 위한 2상 단일군 연구 데이터를 발표할 예정입니다. 이 연구는 영국, 프랑스, 네덜란드에서 진행되었으며, 30명의 성인 GBS 환자에게 표준 치료인 정맥 내 면역글로불린(IVIg)과 병용한 이믈리피다제 단일 용량(0.25 mg/kg)을 평가했습니다.
마르세유 대학병원의 샤람 아타리안 교수는 5월 18일 연구 결과를 발표할 예정입니다. 2024년 12월 처음 발표된 연구 결과에 따르면, 이믈리피다제를 표준 치료 전에 투여하는 것이 안전하고 내약성이 우수했으며, GBS 환자 치료에 큰 가능성을 보여주었습니다.
Hansa Biopharma (HNSA) présentera des données issues de son étude de phase 2 à bras unique sur imlifidase, une enzyme clivant les IgG, pour le traitement du Syndrome de Guillain-Barré (GBS) lors de la réunion annuelle PNS 2025 à Édimbourg. L'étude, réalisée au Royaume-Uni, en France et aux Pays-Bas, a évalué une dose unique d'imlifidase (0,25 mg/kg) en association avec le traitement standard par immunoglobulines intraveineuses (IVIg) chez 30 patients adultes atteints de GBS.
Le professeur Shahram Attarian des Hôpitaux Universitaires de Marseille présentera les résultats le 18 mai. Les résultats de l'étude, initialement communiqués en décembre 2024, ont montré que l'administration d'imlifidase avant le traitement standard était sûre et bien tolérée, démontrant un potentiel significatif pour le traitement des patients atteints de GBS.
Hansa Biopharma (HNSA) wird Daten aus seiner Phase-2-Einzelsarmstudie zu Imlifidase, einem IgG-spaltenden Enzym, zur Behandlung des Guillain-Barré-Syndroms (GBS) auf dem PNS-Jahrestreffen 2025 in Edinburgh vorstellen. Die Studie, die im Vereinigten Königreich, Frankreich und den Niederlanden durchgeführt wurde, bewertete eine Einzeldosis Imlifidase (0,25 mg/kg) in Kombination mit der Standardtherapie intravenöser Immunglobuline (IVIg) bei 30 erwachsenen GBS-Patienten.
Professor Shahram Attarian von den Hopitaux Universitaires de Marseille wird die Ergebnisse am 18. Mai präsentieren. Die im Dezember 2024 erstmals kommunizierten Studienergebnisse zeigten, dass die Verabreichung von Imlifidase vor der Standardtherapie sicher und gut verträglich war und ein erhebliches Potenzial für die Behandlung von GBS-Patienten aufweist.
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Insights
Hansa's Phase 2 GBS study showed positive safety results for imlifidase combined with standard care, representing a potential new treatment option.
The data presentation from Hansa Biopharma's Phase 2 study (15-HMedIdeS-09) represents a significant development in the treatment landscape for Guillain-Barré Syndrome (GBS). GBS is a rare autoimmune disorder where the body's immune system attacks the peripheral nerves, causing rapid-onset muscle weakness that can progress to paralysis and sometimes requires mechanical ventilation.
The study evaluated imlifidase, an IgG-cleaving enzyme, administered prior to standard intravenous immunoglobulin (IVIg) therapy in 30 adult GBS patients. This approach directly targets the pathophysiological mechanism of GBS by rapidly cleaving IgG antibodies that are implicated in nerve damage.
What makes this particularly notable is that current standard treatments for GBS (IVIg or plasma exchange) have limitations in terms of speed of action and efficacy, especially in severe cases. The preliminary findings that imlifidase was "safe and well tolerated" in combination with standard care provides a foundation for potentially faster intervention in this rapidly progressing condition.
The mechanistic rationale is sound – by rapidly cleaving IgG antibodies, imlifidase could potentially halt nerve damage earlier in disease progression, potentially leading to improved recovery outcomes and reduced disability. While specific efficacy data isn't detailed in this release, the fact that the company described the December 2024 results as "positive" suggests promising clinical outcomes.
If successful in further development, this approach could represent the first significant advancement in GBS treatment in decades, addressing an unmet need for faster-acting therapies in a condition where time to treatment directly impacts long-term outcomes.
Hansa communicated the results from the 15-HMedIdeS-09 study in December 2024. Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de
Hitto Kaufmann, Chief R&D Officer, Hansa Biopharma said, "We are pleased to be able to share more detail around the positive data from our 15-HMedIdeS-09 Phase 2 study, which demonstrated the significant potential imlifidase could have in combination with standard of care IVIg for patients with GBS. We know that IgG is a key driver of inflammatory attacks on peripheral nerves and has been clinically linked to the severity and progression of GBS, and that there is a clear and urgent need for new and faster treatment options in GBS. This data offers meaningful insights to help advance the understanding of IgG in GBS and improve patient care."
Lead Author | Abstract Title | Presentation Details |
Pr Shahram Attarian | "Outcome in patients with severe Guillain-Barré Syndrome treated with imlifidase and standard-of-care immunoglobulin" – Oral presentation | 18 May, 11:25. Part of the Richard A.C. Hughes Symposium: Clinical Highlights |
Hansa's Phase 2 15-HMedIdes-09 open-label, single arm study was performed across multi-centers in the
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Notes to editors
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.1 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in
About imlifidase and autoimmune diseases
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.2-4 Pathogenic IgG can contribute to a broad spectrum of autoimmune diseases.
Hansa Biopharma is exploring how imlifidase and HNSA-5487 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 and Guillain-Barré Syndrome (GBS). HNSA-5487 is moving quickly into the clinical phase focusing on patients with myasthenia gravis (MG) and potentially other neuro-autoimmune diseases.
About Guillain-Barré Syndrome
Guillain-Barré Syndrome (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.5 In GBS, rapid onset and progression of muscle weakness occurs and can lead to severe paralysis of the arms and legs. Approximately 25 percent of patients require mechanical ventilation for days to months and 20 percent are unable to walk after six months.6-8 Even with current standard of care - either plasma exchange or IVIg therapy - GBS is fatal in 3
About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
References
- European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.
- Angum F, et al. The Prevalence of Autoimmune Disorders in Women: A Narrative Review. Cureus. 2020 May 13;12(5):e8094. doi: 10.7759/cureus.8094.
- Wang L, et al. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395.
- Ma H, Murphy C, Loscher CE and O'Kennedy R (2022) Autoantibodies – enemies, and/or potential allies? Front. Immunol. 13:953726. doi: 10.3389/fimmu.2022.953726
- McGrogan A, Madle GC, Seaman HE, de Vries CS. The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology. 2009;32(2):150-63. doi: 10.1159/000184748. Epub 2008 Dec 17. PMID: 19088488.Fletcher D, et al. Neurology. 2000 27;54(12):2311-5
- Leonhard SE, Papri N, Querol L, Rinaldi S, Shahrizaila N, Jacobs BC. Guillain-Barré syndrome. Nat Rev Dis Primers. 2024 Dec 19;10(1):97. doi: 10.1038/s41572-024-00580-4. PMID: 39702645.
- Fletcher DD, Lawn ND, Wolter TD, Wijdicks EF. Long-term outcome in patients with Guillain-Barre syndrome requiring mechanical ventilation. Neurology. 2000;54(12):2311–5.
- van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15. PMID: 25023340.
- Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barré syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2. PMID: 26948435.
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