The recent granting of Fast Track designation by the U.S. FDA for our flagship product Diamyd® is a milestone that both accelerates the path to bringing our innovative treatment to patients with Type 1 Diabetes and validates the urgent need for our therapy.
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 disease-modifying investigational medicines 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 precision medicine Phase III trial DIAGNODE-3. Diamyd® is also being evaluated in the prevention Phase II trial DiaPrecise.