The approval further advances the foundation established in patients with HLA DR3-DQ2, a genetically distinct subgroup currently being targeted with the GAD-specific immunotherapy Diamyd^® in the Phase 3 DIAGNODE-3 trial. Similarly, research has shown that individuals with autoimmune diabetes who have the DR4-DQ8 genetic profile may be particularly responsive to treatment with insulin-specific immunotherapy. Up to 90% of Type 1 Diabetes patients carry at least one of these markers, both of which are strongly linked to the disease.

“The granting of this patent marks another critical step forward in developing personalized treatments that address the underlying autoimmune mechanisms driving Type 1 Diabetes”, says Anton Lindqvist, Chief Scientific Officer of Diamyd Medical. “This strengthens the rational for integrating genetic screening into clinical diabetes care, enabling earlier diagnosis and intervention. Importantly, it is also critical for the expansion of our precision medicine portfolio.”

About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^{® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 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. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company’s 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. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. 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 on January 21, 2025, 10:35 CET.