Diamyd Medical has strengthened its intellectual property position in precision medicine for type 1 diabetes with recent patent grants from the Eurasian Patent Office and Hong Kong. The patents protect the use of insulin-based antigens for treating individuals with type 1 diabetes who carry the HLA DR4-DQ8 genetic marker, with protection extending until 2038.
Expanding Genetic Coverage for Type 1 Diabetes Treatment
The newly granted patents complement Diamyd Medical's existing intellectual property for the HLA DR3-DQ2 genetic subgroup, which is currently targeted by the company's investigational GAD-specific immunotherapy, Diamyd®. Research suggests that individuals with the DR4-DQ8 haplotype may benefit from insulin-specific immunotherapy instead of GAD-based treatment.
Together, the HLA DR3-DQ2 and DR4-DQ8 genetic markers are present in up to 90% of individuals with type 1 diabetes, highlighting the broad clinical relevance of this precision medicine approach. The HLA DR3-DQ2 genotype alone constitutes approximately 40% of patients with type 1 diabetes in Europe and the United States.
Global Patent Portfolio
Diamyd Medical now holds granted patents for precision medicine diabetes treatments across multiple key markets:
For treatment and prevention of type 1 diabetes in individuals carrying HLA DR3-DQ2 using Diamyd® (GAD/alum), patents are approved in Europe, Eurasia, Israel, Hong Kong, South Africa, Japan, and South Korea, with protection extending to 2038.
For treatment and prevention of type 1 diabetes in individuals carrying HLA DR4-DQ8 using insulin as an antigen, patents are granted in Europe, South Korea, Eurasia, and Hong Kong, also with patent protection lasting until 2038. Applications for additional countries remain pending.
Clinical Development Progress
Diamyd®, the company's investigational antigen-specific immunomodulatory therapeutic, has received significant regulatory recognition. The U.S. FDA has granted the therapy Orphan Drug Designation and Fast Track Designation for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Additionally, Diamyd® has received Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes.
The confirmatory Phase 3 DIAGNODE-3 trial is actively recruiting patients with recent-onset type 1 diabetes at 60 clinics across eight European countries and the United States. This trial focuses exclusively on patients carrying the HLA DR3-DQ2 genotype and has potential for an accelerated approval pathway in the United States.
Previous clinical results have demonstrated significant outcomes in preserving endogenous insulin production in genetically predefined patient groups, as shown in both a large-scale meta-analysis and the company's prospective European Phase 2b trial.
Manufacturing and Development Infrastructure
Diamyd Medical is developing a biomanufacturing facility in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in Diamyd®. The company also maintains strategic investments as a major shareholder in stem cell company NextCell Pharma AB and artificial intelligence company MainlyAI AB.
