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.
Retogatein (rhGAD65/alum) is under clinical development for individuals with type 1 diabetes carrying the genetic HLA DR3-DQ2 haplotype. Clinical trial data supports the potential of retogatein (rhGAD65/alum) 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.. Preserving endogenous insulin production has been shown to correlate with improved blood glucose control and reduced complications of type 1 diabetes. By preserving the function of the insulin-producing cells there is also the potential to delay the time to or prevent clinical diagnosis of type 1 diabetes.
For more information on clinical results and mechanism of action see Scientific Publications.
A candidate drug passes a number of development stages. Parallel to the discovery, preclinical and clinical phases, a commercially viable manufacturing process must be secured to obtain future market approval.
Retogatein is a suspension for injection containing the active pharmaceutical ingredient GAD65 mixed with the vaccine adjuvant Alhydrogel (alum). The human recombinant protein GAD65 is manufactured in insect cells in a well-controlled GMP process. The manufacturing process is developed for late phase clinical use.
A manufacturing facility is being set up by Diamyd Medical in Umeå, Sweden, with a first priority to receive the process technology for the manufacture of recombinant GAD65.