“These analyses represent a key milestone in our ongoing preparations for the pivotal DIAGNODE-3 trial readout”, says Anton Lindqvist, Chief Scientific Officer of Diamyd Medical. “Understanding and demonstrating the associations between preserved endogenous insulin production and clinical outcomes strengthens confidence in Diamyd’s potential to treat Type 1 Diabetes in a safe, durable, and meaningful way."

The presentation will emphasize the role of C-peptide preservation and its association with HbA1c improvements and continuous glucose monitoring (CGM) metrics in recently diagnosed Type 1 Diabetes patients. Combined data from clinical trials evaluating the safety and efficacy of the investigational immunotherapy Diamyd^® in individuals recently diagnosed with Stage 3 Type 1 Diabetes carrying HLA DR3-DQ2 demonstrate that:

• Treatment significantly and durably preserves C-peptide secretion, a marker of endogenous insulin production.
• Higher levels of therapeutically preserved C-peptide are correlated with improved glycemic control, demonstrated by clinically meaningful reductions in HbA1c on top of standard of care treatment.

Additionally, detailed CGM data analyses from Diamyd Medical’s Phase 2b trial DIAGNODE-2 indicate that C-peptide secretion is significantly (p < 0.05) correlated with 30 of the 42 analyzed metrics, out of which 18 show moderate to strong correlation (p < 0.0001). The strongest correlation is shown for:

• increased time in range (TIR)
• reduced occurrence and duration of severe hyperglycemic episodes
• lower glycemic variability
• lower overall blood glucose

These correlations further underscore the clinical importance of therapeutically maintaining insulin producing beta cell function.

Diamyd Medical's investigational precision immunotherapy has been specifically beneficial in genetically defined patient groups (HLA DR3-DQ2 positive), providing a targeted approach to treatment that aligns with personalized medicine strategies in autoimmune diabetes. Importantly, the FDA has recognized the preservation of C-peptide as a reasonably likely surrogate endpoint in the ongoing pivotal DIAGNODE-3 trial evaluating Diamyd^®, where C-peptide will serve as the primary endpoint for a readout expected around March 2026 that may support an accelerated BLA in the US.

The ATTD presentation is titled “Pathway to accelerated approval for precision medicine in type 1 diabetes” and will be presented by Anton Lindqvist, CSO, on March 20^th.

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 (insulin requiring) Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (not yet insulin requiring) 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. 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 March 17, 2025, 13:45 CET.