The Phase 3 trial is based on the notion of precision medicine, where only individuals that we know beforehand to have a high likelihood of benefitting from the treatment will be enrolled.
10-20% of the more than 463 million living with diabetes suffer from the autoimmune form of the disease, where the immune system destroys the insulin-producing cells. Preserving the insulin producing ability may decrease the risk of complications among patients with autoimmune diabetes by 60-80 percent.
The antigen-specific immunotherapy Diamyd® and the regenerative and immunomodulatory therapy Remygen® are two novel disease-modifying drugs in clinical development phase, aiming to preserve and regenerate the patients’ own insulin production.
The efficacy of intralymphatic administration of Diamyd® on preserving the insulin producing ability in type 1 diabetes is being confirmed in the Phase IIb trial DIAGNODE-2. The safety and efficacy of Remygen® on stimulating growth of insulin producing cells in type 1 diabetes is being evaluated for the first time in the Phase I/II trial ReGenerate-1.