Diamyd Medical's antigen-specific immunotherapy, Diamyd (GAD-Alum), has shown promising results in a pilot trial involving redosing in patients with Type 1 Diabetes. The DIAGNODE-B trial, an investigator-initiated study conducted in Linköping, Sweden, demonstrated the safety and potential efficacy of redosing Diamyd to preserve beta-cell function. The study was published in the International Journal of Molecular Sciences.
The trial included six participants with the HLA DR3-DQ2 haplotype who had previously participated in the DIAGNODE-1 or DIAGNODE-2 trials. These individuals received a fourth or fifth intralymphatic dose of Diamyd along with vitamin D supplementation. Over a 12-month follow-up period, the participants exhibited stabilized endogenous insulin production, as measured by C-peptide levels, improved glycemic control, and reduced insulin requirements.
Clinical and Immunological Outcomes
Key findings from the DIAGNODE-B trial include:
- 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 previous trials.
Diamyd's Role in Type 1 Diabetes Treatment
Diamyd Medical is focused on developing precision medicine therapies for Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd is designed to preserve endogenous insulin production. It has received Orphan Drug Designation in the U.S., as well as Breakthrough Therapy and Fast Track designations from the FDA for Stage 3 Type 1 Diabetes. Fast Track designation has also been granted for Stages 1 and 2.
DIAGNODE-3, a Phase III confirmatory trial, is currently recruiting patients with recent-onset (Stage 3) Type 1 Diabetes across 60 clinics in Europe and the U.S. Prior studies have shown significant results in a genetically predefined patient group, including a large-scale meta-analysis and a 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. This method of injection is intended to optimize treatment response.
Diamyd Medical is also developing a biomanufacturing facility in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in Diamyd.
