The topline results from DIAGNODE-2 will comprise both the primary clinical endpoint and the most important secondary clinical endpoints, as well as the results for the genetically defined subgroups. These results will have an impact on the final design of any upcoming late stage development trials, including the patient population that we will target for the drug label.
10-20% of the more than 400 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.