Type 1 diabetes is a chronic progressive autoimmune disease where the immune system attacks and breaks down the insulin-producing cells in the pancreas. Preserving the insulin producing ability may decrease the risk of complications among patients with autoimmune diabetes by 60-80 %.
Retogatein (rhGAD65/alum) is an investigational antigen-specific immunotherapy for the prevention and treatment of type 1 diabetes. Currently in Phase 3 clinical trials, retogatein has earned Fast Track designation and Orphan Drug Designation from the US FDA.
The efficacy of retogatein (rhGAD65/alum) is being confirmed in the first ever precision medicine Phase 3 trial in individuals with Stage 3 type 1 diabetes, DIAGNODE-3. The safety and feasibility of retogatein in individuals with Stage 1 or Stage 2 type 1 diabetes is evaluated in the Phase 2 trial, DiaPrecise.