A recent publication by Diamyd Medical in the International Journal of Molecular Sciences titled "Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial" showcases the safety and potential efficacy of redosing Diamyd® (GAD-Alum). This antigen-specific immunotherapy aims at preserving beta-cell function in Type 1 Diabetes patients.
The DIAGNODE-B trial, conducted by Prof. Johnny Ludvigsson in Linköping, involved six participants with the genetic HLA DR3-DQ2 haplotype, who had previously participated in the DIAGNODE-1 or DIAGNODE-2 trials. These participants received a fourth or fifth intralymphatic dose of Diamyd® along with vitamin D supplementation. Over a 12-month follow-up, the trial observed stabilized endogenous insulin production, improved glycemic control, and reduced insulin requirements among participants. 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.
Diamyd Medical is focused on developing precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® has received several designations from the U.S. FDA, including Orphan Drug Designation, Breakthrough Designation, and Fast Track Designation for the treatment of Stage 3 Type 1 Diabetes, as well as Fast Track Designation for Stage 1 and 2 Type 1 Diabetes. The company is currently recruiting patients for the DIAGNODE-3, a confirmatory Phase III trial, across 60 clinics in eight European countries and the US.
For more details on the study, visit International Journal of Molecular Sciences.
