Europe to grant precision medicine patent to Diamyd Medical for insulin antigen treatment in autoimmune diabetes

The European Patent Office (EPO) has informed Diamyd Medical that the patent application protecting the use of insulin-based antigens for the treatment of autoimmune diabetes in patients carrying the HLA DR4-DQ8 genetic marker will be granted. The patent, valid until 2035, marks an important step in advancing precision medicine for diabetes care.

The forthcoming EPO patent grant builds on the foundation already established for patients with the HLA DR3-DQ2 genotype, a distinct genetic subgroup currently targeted by Diamyd Medical’s GAD-specific immunotherapy Diamyd® in the ongoing Phase 3 DIAGNODE-3 trial. Research also indicates that individuals with the DR4-DQ8 profile could benefit from insulin-specific immunotherapy. Together, HLA DR3-DQ2 and DR4-DQ8 markers are present in up to 90 % of individuals with Type 1 Diabetes, emphasizing their clinical relevance.

"This is a major validation of our precision medicine strategy for autoimmune diabetes," says Anton Lindqvist, Chief Scientific Officer of Diamyd Medical. "It highlights the importance of genetic profiling in guiding targeted immunotherapies and strengthens our toolbox for providing individualized treatments that change the course of the disease."

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 a 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 is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. An early read-out of the Phase 3 trial is expected in March 2026. 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.

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 on April 28, 2025, 11:10 CET.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

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