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Diamyd
- Development stage
- Phase 2
- Lead developer
- Diamyd Medical
- Modality
- Sublingual Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Subcutaneous Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Administration
- Intranodal Injection
01
Overview
Diamyd is an antigen-specific immunotherapy designed to treat autoimmune diabetes, primarily Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). The active ingredient is recombinant human glutamic acid decarboxylase 65 (GAD65) protein formulated with the adjuvant Alhydrogel (alum). Diamyd works by inducing immunological tolerance against GAD65, aiming to preserve endogenous insulin production by reprogramming immune cells and slowing or halting the autoimmune destruction of pancreatic beta cells. It targets patients with the HLA DR3-DQ2 haplotype and is administered as three intranodal injections one month apart. Diamyd has received Fast Track and Orphan Drug Designations from the US FDA for various stages of Type 1 Diabetes. It is currently in Phase III clinical trials for recent-onset (Stage 3) Type 1 Diabetes and earlier phases for prevention (Stages 1 & 2) as well as LADA[1][4][6][7].
- Brand names
- Diamyd
- Other names
- rhGAD65/alumrecombinant GAD65 formulated in alumGAD-alum
02
Targets
GAD2 (Glutamic Acid Decarboxylase 65)
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