Diamyd® (rhGAD65/alum) is an antigen-specific immunotherapy for the treatment of autoimmune diabetes. Currently in Phase III clinical trials, Diamyd® has earned Fast Track designation and Orphan designation from the US FDA.
Diamyd® targets patients with the genetic HLA DR3-DQ2 haplotype. Clinical data support the potential of Diamyd® 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 using administration of low doses of Diamyd®.
Diamyd® intervenes early in the disease course, with the potential to significantly improve blood glucose control and reduce the complications of Type 1 Diabetes and LADA. Its development extends to treating early-stage Type 1 Diabetes, aiming to prevent or delay progression to clinically diagnosed disease.
Diamyd Medical develops the GABA-based investigational drug Remygen® as a component in the treatment of metabolic diseases.
Preclinical data indicate the potential of GABA as an immunomodulatory and key signalling molecule in the islets of Langerhans found in the pancreas. The effect in metabolic diseases is primarily achieved by activating GABA receptors that affect the function and growth of insulin producing cells in the pancreas.
Remygen® has the potential to slow down or reverse the progression of autoimmune diabetes and type 2 diabetes. Remygen® is in Phase I/II clinical development.
A candidate drug passes several development stages. Parallel to the discovery, preclinical and clinical phases, a commercially viable manufacturing process must be secured to obtain future market approval.
Diamyd® 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 new 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.
Remygen® is a controlled release tablet consisting of the active pharmaceutical ingredient GABA. The GABA substance is chemically synthesized in a well-controlled GMP process together with a global contract manufacturer. The manufacturing process is scalable and pediatric formulations with the same properties can be designed.