The South Korean Patent Office is set to grant Diamyd Medical AB a patent protecting the use of insulin-based antigens for treating autoimmune diabetes in patients carrying the HLA DR4-DQ8 genetic marker. This patent, which remains valid until 2035, establishes South Korea as the first country to approve these specific claims, highlighting the increasing importance of precision medicine in diabetes management.
This approval builds upon the foundation established in patients with HLA DR3-DQ2, a genetically distinct subgroup currently being targeted with Diamyd®, Diamyd Medical's GAD-specific immunotherapy, in the Phase 3 DIAGNODE-3 trial. Research indicates that individuals with autoimmune diabetes and the DR4-DQ8 genetic profile may exhibit a particularly strong response to treatment with insulin-specific immunotherapy. Notably, up to 90% of Type 1 Diabetes patients possess at least one of these markers, both of which are strongly associated with the disease.
Precision Medicine Approach
Anton Lindqvist, Chief Scientific Officer of Diamyd Medical, stated, "The granting of this patent marks another critical step forward in developing personalized treatments that address the underlying autoimmune mechanisms driving Type 1 Diabetes." He further emphasized that this development strengthens the rationale for integrating genetic screening into clinical diabetes care, facilitating earlier diagnosis and intervention. Lindqvist also noted the importance of this patent for the expansion of Diamyd's precision medicine portfolio.
Diamyd Medical's Focus
Diamyd Medical is dedicated to developing precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic designed to preserve endogenous insulin production. The U.S. FDA has granted Diamyd® Orphan Drug Designation, Breakthrough Designation, and Fast Track Designation for the treatment of Stage 3 Type 1 Diabetes, as well as Fast Track Designation for Stages 1 and 2. The DIAGNODE-3 trial, a confirmatory Phase III study, is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes across 60 clinics in eight European countries and the United States. Prior research has demonstrated significant results in a large, genetically predefined patient group, including a large-scale meta-analysis and a prospective European Phase IIb trial where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. This method of injection, which can be performed rapidly, aims to optimize the treatment response.
Diamyd Medical is also developing a biomanufacturing facility in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in Diamyd®. Additionally, Diamyd Medical holds a significant share in NextCell Pharma AB, a stem cell company, and MainlyAI AB, an artificial intelligence company.
