Company Announcements

LUND, Sweden , May 14, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), will present data from its 15-HMedIdeS-09 Phase 2 single arm study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) at the Peripheral Nerve Society (PNS) Annual Meeting, taking place 17-20 May in Edinburgh, Scotland.

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 Marseille (APHM) and International Coordinating Principal Investigator will present data from 15-HMedIdeS-09 Phase 2 study at the 2025 PNS Annual Meeting.

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."

Hansa's Phase 2 15-HMedIdes-09 open-label, single arm study was performed across multi-centers in the UK, France, and the Netherlands evaluating the safety, tolerability, and efficacy of a single dose of imlifidase (0.25 mg/kg) in 30 adult GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg). The administration of imlifidase prior to SoC in patients with GBS was considered to be safe and well tolerated.

--- ENDS ---

Contacts for more information:

Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com 

Stephanie Kenney, VP Global Corporate Affairs
media@hansabiopharma.com 

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 Europe and is marketed under the trade name IDEFIRIX^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.¹

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 3-7% of cases.^6-8 Most GBS patients also have sensory disturbance (tingling or numbness or ataxia) and pain, and some patients have double vision or problems with swallowing. GBS may also involve the respiratory muscles, leading to intensive care unit (ICU) admission and mechanical ventilation.⁹

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 Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.

©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

References

1. 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. 
2. 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.
3. Wang L, et al. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395. 
4. 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
5. 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
6. 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.
7. 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.
8. 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.
9. 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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