Hansa Biopharma Completes Enrolment in Global Pivotal Phase 3 Trial of imlifidase in Anti-Glomerular Basement Membrane Disease
Hansa Biopharma has completed patient enrollment in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial testing imlifidase for anti-glomerular basement membrane (anti-GBM) disease. The trial enrolled 50 patients across 40+ centers in the US, UK, and EU, ahead of the original 2025 schedule. The study randomized 25 patients to receive imlifidase plus standard of care (SoC) and 25 to receive SoC alone.
The trial aims to evaluate kidney function improvement through estimated glomerular filtration rate (eGFR) and dialysis needs at 6 months. Anti-GBM is a rare autoimmune condition affecting 1.6 people per million annually, with most patients losing kidney function. Imlifidase has received orphan drug designation from both FDA and EMA. Results are expected in 2025.
Hansa Biopharma ha completato l'arruolamento dei pazienti nella sperimentazione GOOD-IDES-02, uno studio globale fondamentale di Fase 3 che testa l'imlifidase per la malattia anti-membrana basale glomerulare (anti-GBM). Lo studio ha arruolato 50 pazienti provenienti da oltre 40 centri negli Stati Uniti, Regno Unito e UE, anticipando il programma originale previsto per il 2025. Lo studio ha randomizzato 25 pazienti a ricevere imlifidase più standard di cura (SoC) e 25 a ricevere solo SoC.
Lo scopo dello studio è valutare il miglioramento della funzione renale attraverso il tasso di filtrazione glomerulare stimato (eGFR) e le necessità di dialisi dopo 6 mesi. L'anti-GBM è una condizione autoimmune rara che colpisce 1,6 persone per milione all'anno, con la maggior parte dei pazienti che perde la funzione renale. L'imlifidase ha ricevuto la designazione di farmaco orfano sia dalla FDA che dall'EMA. I risultati sono attesi per il 2025.
Hansa Biopharma ha completado la inscripción de pacientes en el ensayo GOOD-IDES-02, un ensayo clínico pivotal global de Fase 3 que prueba imlifidase para la enfermedad de la membrana basal glomerular (anti-GBM). El ensayo inscribió a 50 pacientes en más de 40 centros en EE. UU., Reino Unido y UE, adelantándose al cronograma original de 2025. El estudio randomizó a 25 pacientes para recibir imlifidase más el estándar de atención (SoC) y a 25 para recibir solo SoC.
El objetivo del ensayo es evaluar la mejora de la función renal a través de la tasa de filtración glomerular estimada (eGFR) y las necesidades de diálisis a los 6 meses. La enfermedad anti-GBM es una condición autoinmune rara que afecta a 1.6 personas por millón anualmente, con la mayoría de los pacientes perdiendo la función renal. Imlifidase ha recibido la designación de medicamento huérfano tanto de la FDA como de la EMA. Se esperan resultados para 2025.
한사 바이오파마가 항사구체 기저막 질환(항-GBM) 치료를 위한 imlifidase의 글로벌 주요 3상 시험인 GOOD-IDES-02 임상 시험에서 환자 등록을 완료했습니다. 이 시험은 미국, 영국 및 유럽의 40개 이상의 센터에서 50명의 환자를 모집하였으며, 원래 계획인 2025년보다 앞서 진행되었습니다. 연구에서는 25명의 환자에게 imlifidase와 표준 치료(SoC)를 제공하고, 나머지 25명에게는 SoC만 제공하도록 무작위 배정되었습니다.
이 시험의 목적은 6개월 후 예상 사구체 여과율(eGFR)과 투석 필요성을 통해 신장 기능 개선을 평가하는 것입니다. 항-GBM은 연간 백만 명당 1.6명이 영향을 받는 희귀 자가면역 질환으로, 대부분의 환자가 신장 기능을 잃게 됩니다. Imlifidase는 FDA와 EMA로부터 희귀의약품으로 지정받았습니다. 결과는 2025년에 발표될 예정입니다.
Hansa Biopharma a achevé l'inscription des patients dans l'essai GOOD-IDES-02, un essai clinique pivot mondial de Phase 3 testant l'imlifidase pour la maladie de la membrane basale glomérulaire (anti-GBM). L'essai a recruté 50 patients dans plus de 40 centres aux États-Unis, au Royaume-Uni et dans l'UE, devançant le calendrier initial de 2025. L'étude a randomisé 25 patients pour recevoir l'imlifidase plus le traitement standard (SoC) et 25 autres pour recevoir uniquement le SoC.
L'objectif de l'essai est d'évaluer l'amélioration de la fonction rénale par le biais du taux de filtration glomérulaire estimé (eGFR) et des besoins en dialyse après 6 mois. L'anti-GBM est une affection auto-immune rare touchant 1,6 personne par million chaque année, la plupart des patients perdant leur fonction rénale. L'imlifidase a reçu la désignation de médicament orphelin par la FDA et l'EMA. Les résultats sont attendus pour 2025.
Hansa Biopharma hat die Patientenrekrutierung in der GOOD-IDES-02-Studie abgeschlossen, einem globalen entscheidenden Phase-3-Studie, die Imlifidase zur Behandlung von Krankheiten der anti-glomerulären Basalmembran (anti-GBM) testet. In der Studie wurden 50 Patienten aus über 40 Zentren in den USA, Großbritannien und der EU rekrutiert, was dem ursprünglichen Zeitplan von 2025 vorausging. Die Studie randomisierte 25 Patienten zur Behandlung mit Imlifidase plus Standardbehandlung (SoC) und 25 zur alleinigen Standardbehandlung (SoC).
Die Studie zielt darauf ab, die Verbesserung der Nierenfunktion durch die geschätzte glomeruläre Filtrationsrate (eGFR) und den Dialysebedarf nach 6 Monaten zu bewerten. Anti-GBM ist ein seltenes autoimmunes Leiden, das jährlich 1,6 Personen pro Million betrifft, wobei die meisten Patienten ihre Nierenfunktion verlieren. Imlifidase hat von der FDA und der EMA eine Orphan-Drug-Einstufung erhalten. Die Ergebnisse werden für 2025 erwartet.
- Early completion of patient enrollment ahead of 2025 schedule
- Orphan drug designation granted by both FDA and EMA
- Large-scale trial involving 40+ centers across US, UK, and EU
- None.
Insights
Data from the trial is expected to be shared in 2025
Søren Tulstrup, President and CEO, Hansa Biopharma said, "We are very pleased with the fast enrolment of all 50 patients in the GOOD-IDES-02 trial. The completion of patient enrolment in this pivotal Phase 3 trial is an important milestone in our efforts to investigate the potential role for imlifidase to address the high unmet need in anti-GBM. The majority of patients with anti-GBM today lose kidney function and two-thirds experience kidney failure requiring long-term dialysis. We look forward to sharing further updates on the outcome of the study and potential path forward in 2025."
Anti-GBM is Hansa Biopharma's most advanced program in the autoimmune space. GOOD-IDES-02 is an open label, multi-center Phase 3 trial involving over 40 centers across the US,
More information about the trial is available at ClinicalTrials.gov under NCT05679401.
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 anti-GBM disease
Anti-glomerular basement membrane (anti-GBM) disease, also known as Goodpasture disease, is a rare, severe autoimmune condition affecting around 1.6 people per million annually1 with majority of patients losing their kidney function.2,3 In anti-GBM disease, the immune system mistakenly develops antibodies against an antigen intrinsic to the glomerular basement membrane, resulting in an acute immune attack of the kidneys and, in around half of the patients, also the lungs. Approximately two thirds of anti-GBM patients will experience kidney failure and require long-term dialysis while awaiting potential kidney transplantation.4 Some patients may also experience bleeding from the lungs. In one out of six patients, anti-GBM disease can become fatal during the acute phase.
Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.5 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.6-8 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).
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. Hansa Biopharma has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma has a rich and expanding research and development program based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. 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. Canney M, et al. Spatial and Temporal Clustering of Anti-Glomerular Basement Membrane Disease. Clin J Am Soc Nephrol. 2016 Aug 8;11(8):1392-1399. doi: 10.2215/CJN.13591215.
2. McAdoo SP, Pusey CD. Anti-Glomerular Basement Membrane Disease. Clin J Am Soc Nephrol. 2017 Jul 7;12(7):1162-1172. doi: 10.2215/CJN.01380217
3. Kluth DC, Rees AJ. Anti-glomerular basement membrane disease. J Am Soc Nephrol. 1999 Nov;10(11):2446-53. doi: 10.1681/ASN.V10112446.
4. Hellmark T, Segelmark M. Diagnosis and classification of Goodpasture's disease (anti-GBM). J Autoimmun. 2014 Feb-Mar;48-49:108-12. doi: 10.1016/j.jaut.2014.01.024.
5. 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.
6. 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.
7. Wang L, et al. Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395.
8. 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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FAQ
What is the primary objective of Hansa Biopharma's GOOD-IDES-02 Phase 3 trial for imlifidase (HNSA)?
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