TARGETING THE UNDERLYING CAUSES OF DIABETES

 

We develop two novel disease-modifying drugs, the antigenspecific immunotherapy Diamyd® and the oral regenerative and immunomodulatory therapeutic Remygen®

Diamyd® and Remygen® have the potential to make a significant difference in the daily life of patients diagnosed with diabetes

MECHANISM of ACTION

Diamyd®

Antigen-specific intralymphatic immunotherapy Diamyd®

Diamyd® is a novel antigen-specific immunotherapy for the treatment of autoimmune diabetes. Diamyd® is based on the protein GAD65, an activator of the immune system involved in the pathology of autoimmune diabetes.

Preventing destruction of insulin producing cells

Clinical data indicate the potential of Diamyd® to slow down or halt the autoimmune destruction of insulin producing beta cells. The effect is achieved through antigenspecific reprogramming of immune cells using ultrasound guided administration of low doses of Diamyd® into superficial lymph nodes.

Reducing complications of autoimmune diabetes

By preventing the autoimmune destruction of insulin producing cells, Diamyd® has the potential to significantly reduce the complications of type 1 diabetes and LADA. Diamyd® is in Phase IIb clinical development.

Remygen®

Regenerative therapy Remygen®

Remygen® is a regenerative and immunomodulatory therapy for the treatment of autoimmune diabetes and type 2 diabetes. Remygen® is based on GABA, a key cell signaling molecule in the islets of Langerhans found in the pancreas.

Stimulating growth of insulin producing cells

Preclinical data indicate the potential of GABA to stimulate growth and function of insulin producing beta cells. The effect is primarily achieved by increasing the levels of GABA in the blood, thereby activating GABA receptors that affect the function and growth of insulin producing cells in the pancreas.

Reversing progression of diabetes

By stimulating the growth and function of insulin producing beta cells, Remygen® has the potential to reverse the progression of autoimmune diabetes and type 2 diabetes. Remygen® is in Phase Ib/IIa clinical development.

 

DEVELOPMENT PROCESS

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.

 

Diamyd® manufacture

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 together with an experienced contract manufacturer. The manufacturing process is developed for late phase clinical use. Diamyd Medical has drug ready for use in clinical trials through 2021.

Remygen® manufacture

Remygen® is a controlled release tablet consisting of the active pharmaceutical ingredient GABA. GABA is a small molecule 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.