Diamyd® (rhGAD65/alum) is an antigen-specific immunotherapy for the treatment of autoimmune diabetes. Currently in Phase III clinical trials, Diamyd® has earned Fast Track designation and Orphan designation from the US FDA.
Diamyd® targets patients with the genetic HLA DR3-DQ2 haplotype. Clinical data support the potential of Diamyd® to slow down or halt the autoimmune destruction of insulin producing beta cells where the effect is achieved through antigen-specific reprogramming of immune cells using administration of low doses of Diamyd®.
Diamyd® intervenes early in the disease course, with the potential to significantly improve blood glucose control and reduce the complications of Type 1 Diabetes and LADA. Its development extends to treating early-stage Type 1 Diabetes, aiming to prevent or delay progression to clinically diagnosed disease.
A candidate drug passes several development stages. Parallel to the discovery, preclinical and clinical phases, a commercially viable manufacturing process must be secured to obtain future market approval.