Novel Drug & Emergent Therapeutics | Autoimmune Diseases | Serum IgG Diseases
Hansa Biopharma Reports Promising 12-Month Results for Next-Gen IgG-Cleaving Therapy in Autoimmune Disease
Time to read: 1 minute, 2 seconds
Originally published: 7 October 2024
Source: PR Newswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDC004
Category: Autoimmune Diseases
Crossreference: IgG Driven Diseases
Keywords: IgG, HNSA-5487, autoimmune diseases, Myelin Oligodendrocyte Glycoprotein Antibody Disease, Neuromylelitis Optica, and Myasthenia Gravis
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Phase 1 FIH Trial |
7 October 2024, PR Newswire Boston
Hansa Biopharma AB has announced encouraging results from a 12-month follow-up analysis of their NICE-01 trial for HNSA-5487, their next-generation IgG-cleaving molecule.
The study demonstrated that HNSA-5487 rapidly reduced IgG levels by over 95% within hours of treatment, with levels returning to normal range six months after initial dosing. Importantly, no serious adverse events were observed, and the treatment was found to be safe and well-tolerated.
The trial revealed that HNSA-5487 has lower pre-treatment anti-drug antibody (ADA) levels and significantly reduced ADA responses compared to imlifidase, Hansa's first-generation IgG-cleaving enzyme. This indicates an attractive immunogenicity profile with clear redosing potential. The treatment also showed consistently robust IgG reduction in nearly all analyzed serum samples.
Looking ahead, Hansa plans to focus clinical development of HNSA-5487 on chronic autoimmune diseases, specifically targeting conditions such as Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD), Neuromylelitis Optica (NMO), and Myasthenia Gravis (MG). These diseases currently have high unmet medical needs, especially in their acute phases.
The NICE-01 trial, a double-blind, randomized, placebo-controlled study involving 36 healthy adult participants, has provided Hansa with confidence in HNSA-5487's potential to address significant unmet needs across a spectrum of IgG-driven diseases and conditions, particularly in autoimmune disorders where better management of immune system attacks is crucial.
Access Original Press Release
7 October 2024 | PR Newswire | Hansa Biopharma's HNSA-5487 Achieved Rapid and Highly Robust IgG Reduction by More Than 95% and Clear Redosing Potential in First-in-Human Trial
7 October 2024 | Hansa Biopharma AB | Corporate Presentation | 12 month analysis | HNSA-5487 demonstrates very rapid and highly robust IgG reduction and clear redosing potentialin Phase 1 FIH trial (PDF)
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