New publication highlights safety and potential benefits of redosing Diamyd® precision medicine for Type 1 Diabetes

Diamyd Medical announces the publication of the article titled "Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial" in the peer-reviewed journal International Journal of Molecular Sciences. The article describes the investigator-initiated clinical trial DIAGNODE-B, conducted in Linköping by Prof. Johnny Ludvigsson, which demonstrates the safety and potential efficacy of redosing Diamyd^® (GAD-Alum), an antigen-specific immunotherapy aimed at preserving beta-cell function in Type 1 Diabetes.

The trial included six participants carrying the genetic HLA DR3-DQ2 haplotype, who had previously enrolled in the DIAGNODE-1 or DIAGNODE-2 trials in Sweden. In the DIAGNODE-B trial, these participants received a fourth or fifth intralymphatic dose of Diamyd^® alongside vitamin D supplementation. Over a 12-month follow-up, participants displayed stabilized endogenous insulin production measured as C-peptide levels, improved glycemic control, and reduced insulin requirements. Immunological markers also indicated sustained immune modulation.

Key Highlights:

• Safety: No severe adverse events were reported, confirming the tolerability of redosing Diamyd^®.
• Clinical Benefits: Participants experienced stable HbA1c levels, increased time in the glycemic target range, and reduced daily insulin doses.
• Immunological Insights: Increased GAD65-induced cytokine responses and antibody titers were observed, consistent with prior trials.

For more details, access the full study at https://www.mdpi.com/3120132.

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 lymphnode 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.