HLA DR3-DQ2, a genetic variant strongly associated with autoimmunity against GAD, is one of the most common genetic risk factors for Type 1 Diabetes, with up to 40 % of individuals with the disease carrying this gene.

A large-scale meta-analysis published in Diabetologia (2020) demonstrated that HLA DR3-DQ2 positivity is linked to a clinical response to the antigen-specific immunotherapy Diamyd^®. This finding was prospectively confirmed in the Phase 2b DIAGNODE-2 trial, published in Diabetes Care (May 2021).

Further follow-up analyses, published in Diabetes, Obesity & Metabolism and The Journal of Clinical Endocrinology & Metabolism (2022), reinforced these results, showing that Diamyd^® preserves endogenous insulin production, leading to statistically significant and clinically relevant improvements in blood glucose control.

The patent, valid until 2038, has in addition to Mexico also been granted in Europe, Japan, China, Hong Kong, Australia, South Africa, Eurasia and Canada, with additional countries pending.

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 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. 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. 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. 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 February 20, 2025, 16:15 CET.