The Eurasian Patent Office has informed Diamyd Medical that the patent application protecting the use of insulin-based antigens for the treatment of individuals with type 1 diabetes carrying the HLA DR4-DQ8 genetic marker will be granted. The patent is valid until 2038.
The forthcoming Eurasian patent grant strengthens Diamyd Medical's intellectual property portfolio, building on the established foundation for patients with the HLA DR3-DQ2 haplotype - a distinct genetic subgroup currently targeted by the company's investigational GAD-specific immunotherapy, Diamyd®, in the ongoing Phase 3 DIAGNODE-3 trial. Research suggests that individuals with the DR4-DQ8 haplotype may instead benefit from insulin-specific immunotherapy. Together, these two genetic markers - HLA DR3-DQ2 and DR4-DQ8 - are present in up to 90% of individuals with type 1 diabetes, underscoring their broad clinical relevance.
Diamyd Medical holds granted patents for these innovative diabetes treatments in key global markets:
- Treatment and prevention of type 1 diabetes in individuals carrying HLA DR3-DQ2 using Diamyd® (GAD/alum) is approved in Europe, Eurasia, Israel, Hong Kong, South Africa, Japan, and South Korea, with patent protection extending to 2038. Applications for additional countries are currently pending.
- Treatment and prevention of type 1 diabetes in individuals carrying HLA DR4-DQ8 using insulin as an antigen is approved in Europe, South Korea, and Eurasia, with patent protection also lasting until 2038, and is pending in several other territories.
This comprehensive patent coverage supports Diamyd Medical's mission to advance precision therapies for type 1 diabetes.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes. Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying the HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial with potential for an accelerated approval pathway in the US is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a largescale meta-analysis as well as in the Company's prospective European Phase IIb trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with Type 1 Diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was provided by the contact person above, for publication at 09:00 CET, September 10, 2025.
