Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study and comparative analysis of imlifidase in patients with Guillain-Barré Syndrome
Hansa Biopharma announced positive full results from its Phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS). The study showed that severe GBS patients treated with imlifidase plus IVIg achieved faster recovery, with a median time of 16 days to walk independently. The treatment demonstrated significant advantages compared to standard IVIg therapy alone, with patients walking independently 6 weeks sooner than the control group.
Key findings include: 37% of patients could walk independently within the first week, 67% by eight weeks, and 63% could run or had no functional disability after six months. The comparative analysis showed patients were 6.4 times more likely to walk independently at week 1 and 4.2 times more likely at week 4 compared to the control group.
Hansa Biopharma ha annunciato risultati positivi completi del suo studio di Fase 2 su imlifidase nella sindrome di Guillain-Barré (GBS). Lo studio ha mostrato che i pazienti con GBS severo trattati con imlifidase più IVIg hanno raggiunto una ripresa più rapida, con un tempo mediano di 16 giorni per camminare in modo indipendente. Il trattamento ha dimostrato vantaggi significativi rispetto alla terapia standard con IVIg da sola, con i pazienti in grado di camminare in modo indipendente 6 settimane prima rispetto al gruppo di controllo.
I risultati chiave includono: il 37% dei pazienti è riuscito a camminare in modo indipendente entro la prima settimana, il 67% entro otto settimane e il 63% è riuscito a correre o non presentava disabilità funzionale dopo sei mesi. L'analisi comparativa ha mostrato che i pazienti avevano 6,4 volte più probabilità di camminare in modo indipendente alla settimana 1 e 4,2 volte più probabilità alla settimana 4 rispetto al gruppo di controllo.
Hansa Biopharma anunció resultados completos positivos de su estudio de Fase 2 sobre imlifidase en el síndrome de Guillain-Barré (GBS). El estudio mostró que los pacientes con GBS severo tratados con imlifidase más IVIg alcanzaron una recuperación más rápida, con un tiempo mediano de 16 días para caminar de manera independiente. El tratamiento demostró ventajas significativas en comparación con la terapia estándar de IVIg por sí sola, con pacientes caminando de forma independiente 6 semanas antes que el grupo de control.
Los hallazgos clave incluyen: el 37% de los pacientes pudo caminar de forma independiente dentro de la primera semana, el 67% en ocho semanas y el 63% pudo correr o no tenía discapacidad funcional después de seis meses. El análisis comparativo mostró que los pacientes tenían 6.4 veces más probabilidades de caminar de forma independiente en la semana 1 y 4.2 veces más probabilidades en la semana 4 en comparación con el grupo de control.
한사 바이오파마는 임리피다제에 대한 길랑-바레 증후군(GBS) 임상 2상 연구의 긍정적인 최종 결과를 발표했습니다. 연구는 중증 GBS 환자들이 임리피다제와 IVIg 치료를 통해 더 빠른 회복을 달성했으며, 독립적으로 걷기까지의 중간 시간이 16일이었음을 보여주었습니다. 이 치료법은 표준 IVIg 치료에 비해 유의미한 장점을 보여주었으며, 환자들은 대조군보다 6주 빨리 독립적으로 걷는 것으로 나타났습니다.
주요 발견사항은: 환자의 37%가 첫 주 내에 독립적으로 걸을 수 있었고, 8주 시점에는 67%, 6개월 후에는 63%가 달리거나 기능적 장애가 없었습니다. 비교 분석 결과 환자들은 1주차에 비해 6.4배, 4주차에 비해 4.2배 더 독립적으로 걸을 가능성이 높았습니다.
Hansa Biopharma a annoncé des résultats complets positifs de son étude de phase 2 sur imlifidase dans le syndrome de Guillain-Barré (GBS). L'étude a montré que les patients atteints de GBS sévère traités avec imlifidase et IVIg ont connu une récupération plus rapide, avec un temps médian de 16 jours pour marcher de manière indépendante. Le traitement a démontré des avantages significatifs par rapport à la thérapie standard à base d'IVIg seule, les patients marchant de manière indépendante 6 semaines plus tôt que le groupe de contrôle.
Les principales conclusions comprennent : 37 % des patients ont pu marcher de manière indépendante au cours de la première semaine, 67 % après huit semaines et 63 % pouvaient courir ou n'avaient aucune incapacité fonctionnelle après six mois. L'analyse comparative a montré que les patients étaient 6,4 fois plus susceptibles de marcher de manière indépendante à la semaine 1 et 4,2 fois plus susceptibles à la semaine 4 par rapport au groupe de contrôle.
Hansa Biopharma hat vollständige positive Ergebnisse aus seiner Phase-2-Studie zu imlifidase bei Guillain-Barré-Syndrom (GBS) bekannt gegeben. Die Studie zeigte, dass schwer erkrankte GBS-Patienten, die mit Imlifidase plus IVIg behandelt wurden, schneller genesen konnten, mit einer medianen Zeit von 16 Tagen, um unabhängig zu gehen. Die Behandlung zeigte erhebliche Vorteile im Vergleich zur Standardtherapie mit IVIg allein, wobei die Patienten 6 Wochen früher unabhängig gehen konnten als die Kontrollgruppe.
Wichtige Ergebnisse umfassen: 37 % der Patienten konnten innerhalb der ersten Woche unabhängig gehen, 67 % nach acht Wochen und 63 % konnten nach sechs Monaten laufen oder hatten keine funktionalen Einschränkungen. Die vergleichende Analyse zeigte, dass die Patienten in der ersten Woche 6,4-mal wahrscheinlicher unabhängig gehen konnten und in der vierten Woche 4,2-mal wahrscheinlicher im Vergleich zur Kontrollgruppe.
- Phase 2 study met primary endpoints with significant efficacy results
- Patients achieved independent walking 6 weeks faster than control group
- 37% of patients walking independently within first week
- 63% of patients showing no functional disability after 6 months
- Treatment was well tolerated with no major safety concerns
- Three patients had to be re-diagnosed during the study
- Small study size of only 27 patients in efficacy analysis
Insights
The Phase 2 study results for imlifidase in GBS represent a significant clinical breakthrough. The data shows patients treated with imlifidase plus IVIg achieved independent walking 6 weeks sooner than the standard-of-care group, with 37% walking independently within just one week. The rapid IgG clearance mechanism appears to effectively halt nerve damage progression.
Most notably, patients were 6.4 times more likely to walk independently at week 1 and 4.2 times more likely at week 4 compared to the control group. The 63% of patients able to run or having no functional disability at 6 months demonstrates strong durability of response. These robust efficacy metrics and clean safety profile position imlifidase as a potential game-changing treatment option for severe GBS patients.
This positive Phase 2 data significantly derisks Hansa's GBS program and strengthens the company's IgG-cleaving platform validation beyond transplantation. The dramatic improvement in recovery time could translate to substantial healthcare cost savings through reduced hospitalization and disability periods. With GBS affecting approximately 100,000 people annually worldwide, successful commercialization could represent a meaningful revenue opportunity.
The data also bolsters confidence in Hansa's broader autoimmune disease strategy, particularly for their second-generation compound HNSA-5487 in development for myasthenia gravis. The strong efficacy shown in GBS suggests the IgG-cleaving mechanism could be valuable across multiple autoimmune indications, expanding the platform's commercial potential.
Data from the 15-HMedIdeS-09 study demonstrated that severe GBS patients treated with a single dose of imlifidase (0.25 mg/kg) plus intravenous immunoglobulin (IVIg) had rapid overall improvement in functional status including expedited recovery of muscle strength, fast return to independently walking, and a median time to independently walk (e.g., reaching Guillain-Barré Syndrome Disability Scale (GBS DS) 2 or less) by 16 days.
The indirect treatment comparison concluded that patients in the 15-HMedIdeS-09 study treated with imlifidase plus IVIg returned to independently walking 6 weeks sooner when compared to severe GBS patients in the IGOS real-world comparator group treated with IVIg. Additionally, patients in the 15-HMedIdeS-09 study experienced statistically significant improvement across several clinically meaningful measures at multiple time points as compared to the IGOS real-world comparator group including 6.4 times more likely at week 1, and 4.2 times more likely at week 4 to walk independently.
Hitto Kaufmann, Chief R&D Officer, Hansa Biopharma said, "Our Phase 2 study results and the indirect treatment comparison with IGOS are critically important. Together they demonstrate the significant role imlifidase may play in future treatment options for GBS patients. Unlike other molecules, imlifidase can effectively and very rapidly remove IgG through enzymatic cleavage - halting the progression of nerve damage associated with GBS and stopping disease progression. The main goal of improved GBS treatments is to stop nerve damage early, reducing the time of hospitalization and support patients in regaining independence sooner. These findings underscore the role pathogenic IgG plays in severity and progression of GBS, and the clear potential of imlifidase to address unmet need in IgG-driven autoimmune diseases where faster acting treatment options are needed."
In GBS, IgG is a key driver of inflammatory attacks on peripheral nerves and has been clinically linked to the severity and progression of the disease. Rapid reduction of IgG levels has the potential to benefit GBS patients by depleting pathological IgG antibodies, thereby halting disease progression resulting in faster recovery and less severe disease.1 Improvement in GBS DS is important because it directly affects the clinical outcomes, recovery, and quality of life for patients. Better management of disease severity can help reduce the risk of life-threatening complications, shorten recovery time, prevent long-term disability, lower healthcare costs, and improve overall patient well-being.
Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de
Key Results: 15-HMedIdeS-09 Study
The 15-HMedIdeS-09 study included 30 adult patients who were treated with imlifidase plus IVIg. During the study, three patients were re-diagnosed, and the remaining 27 patients received a confirmatory diagnosis of severe GBS and were included in the efficacy analysis.
By the first week,
The median time to improve by at least one grade in the GBS DS was six days. By eight weeks,
Key Results: Indirect Treatment Comparison of 15-HMedIdeS-09 Study with Real-World Comparator Group
When compared to the IGOS real-world comparator group (severe GBS patients treated with IVIg, n=754), patients in the 15-HMedIdeS-09 study (severe GBS patients treated with imlifidase in combination with IVIg, n=27) experienced significantly faster improvement in disability as measured by the GBS DS.
Patients in the 15-HMedIdeS-09 study improved by at least one step on the GBS DS, 3 weeks sooner (p=0.002) and returned to independently walking (GBS DS≤2) 6 weeks sooner versus patients in the IGOS real-world comparator group treated with IVIg (p=0.03).
Moreover, patients in the 15-HMedIdeS-09 study were more likely to quickly regain the ability to independently walk than the IGOS real-world comparator group treated with IVIg. At one week, patients in the 15-HMedIdeS-09 study were 6.4 times more likely (odds ratio
Hansa is developing novel immunomodulating biologic therapies based on its proprietary, first in class IgG cleaving platform and is focused on IgG driven immune mediated disease where there is high unmet medical need and little to no treatment options. The company has two IgG cleaving compounds. Imlifidase is a first generation, first in class, single dose therapy with proven efficacy and safety. It's conditionally approved in the EU for desensitization in kidney transplantation. HNSA-5487 is a second-generation molecule with redosing potential with a clinical development path focused on acute exacerbations in neuro-autoimmune disease including myasthenia gravis (MG).
The company plans to publish data from the study and indirect comparison. More information about the study is available at ClinicalTrials.gov under NCT03943589.
Hansa Biopharma will host a telephone conference on 18 December at 14:00 CET / 8:00 AM ET.
Slides used in the presentation will be available online following the call.
To participate in the telephone conference, please use the dial-in details provided below:
Participant Dial In (Toll Free): 1-877-270-2148
Participant International Dial In: 1-412-902-6510
*Please ask to be joined into the Hansa Biopharma call
Join the webcast here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=b3UzB3xg
This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 21:40 CET on 17 December 2024.
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 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.2 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.3,4 Even with current standard of care - either plasma exchange or IVIg therapy - GBS is fatal in 3
About Guillain-Barré Syndrome Disability Scale
The Guillain-Barré Syndrome Disability Scale (GBS DS) is a tool used to evaluate a patient's functional outcome and motor function. A disability score of 0 represents a normal condition; 1 indicates the patient has mild symptoms and is capable of running; 2 indicates the patient is able to walk 10 meters independently but is unable to run; 3 indicates the patient is able to walk only with assistance; 4 indicates the patient is bedridden or chair-bound; 5 indicates the patient is mechanically ventilated, and a score of 6 indicates the patient is deceased.
About GBS Medical Research Council Score
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). The MRC sum score was first described by Kleyweg et al (1988) for use in the Dutch Guillain-Barré trial. This score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic).7 The MRC sum score is used to monitor changes in muscle strength over time, assess the severity of GBS at diagnosis, and determine the need for further treatment interventions.8
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.9 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 15-HMedIdes-09 study
15-HMedIdes-09 is an open-label, single arm, multi-center study across the
About Hansa 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.10-12 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 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 second-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in
©2024 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
References
1. Yuki N, Hartung HP (June 2012). "Guillain-Barré syndrome". The New England Journal of Medicine. 366 (24): 2294–304. doi:10.1056/NEJMra1114525. PMID 22694000.
2. McGrogan A, et al. Neuroepidemiology. 2009; 32(2):150-63
3. Fletcher D, et al. Neurology. 2000 27;54(12):2311-5
4. Van Doorn P. Presse Med. 2013;42(6 Pt 2):e193-201.
5. Van den Berg B, et al., Nat Rev Neurol. 2014; Aug;10(8):469-82
6. Willison, Hugh J et al. Guillain-Barré syndrome. The Lancet, Volume 388, Issue 10045, 717 - 727
7. Kleyweg, R.P., Van Der Meché, F.G.A. and Schmitz, P.I.M. (1991), Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve, 14: 1103-1109. https://doi.org/10.1002/mus.880141111
8. Leonhard, S.E., Mandarakas, M.R., Gondim, F.A.A. et al. Diagnosis and management of Guillain–Barré syndrome in ten steps. Nat Rev Neurol 15, 671–683 (2019). https://doi.org/10.1038/s41582-019-0250-9
9. 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.
10. Angum F, et al. The Prevalence of Autoimmune Disorders in Women: A Narrative Review. Cureus. 2020 May. 12(5):e8094. doi: 10.7759/cureus.8094.
11. Wang L, et al. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395.
12. 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
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