Diamyd Medical has achieved a significant milestone in its pioneering Phase 3 trial, DIAGNODE-3, of Diamyd in Type 1 Diabetes, marking the successful enrollment of 100 patients without any serious adverse events or discontinuations reported. This trial, the first-ever precision medicine Phase 3 study in Type 1 Diabetes, is currently underway in the United States and eight European countries, including Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary, and Estonia.

Ulf Hannelius, President & CEO of Diamyd Medical, expressed his satisfaction with the trial’s progress, stating, “This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convenience of the treatment.” He also acknowledged the dedication of the participants and the clinical staff involved in the trial.

The DIAGNODE-3 trial is distinctive not only for its scale but also for its focus on patients who carry the HLA DR3-DQ2 haplotype, a genetic marker associated with a positive response to the antigen-specific immunotherapy Diamyd®. This therapy was granted Fast Track designation by the FDA in February 2024 and has also received Orphan Drug designation in the U.S. The trial aims to enroll up to 330 individuals aged 12 to 29 who were recently diagnosed (within 6 months) with Type 1 Diabetes.

The selection of participants for DIAGNODE-3 is based on extensive prior research, including the Phase IIa and IIb trials DIAGNODE-1 and DIAGNODE-2, and a large-scale meta-analysis incorporating data from over 600 individuals across earlier Phase II and III trials using Diamyd. This strategic patient selection enhances the trial’s likelihood of achieving its co-primary endpoints, which focus on the preservation of endogenous insulin production capacity (measured by stimulated C-peptide) and improved blood glucose control (determined by HbA1c levels).

Additionally, the trial includes a further stratification for HLA haplotypes to identify a potential super responder group, characterized by individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. This genetic testing, which is critical for participant selection, is widely available and well-established.

Expert Opinion: The DIAGNODE-3 trial by Diamyd Medical is a trailblazing effort in the field of Type 1 Diabetes, aiming to transform treatment paradigms through precision medicine. By targeting genetic subgroups within the diabetic population, Diamyd Medical is not only enhancing the efficacy of its treatment but also paving the way for more personalized healthcare solutions in chronic disease management.

Funding and Support: The trial is partially supported by JDRF, the leading global type 1 diabetes research and advocacy organization, highlighting the significant community and scientific backing for this research.

  antigen-specific immunotherapy, DIAGNODE-3, Diamyd Medical, FDA Fast Track, HLA DR3-DQ2 haplotype, Precision Medicine, Type 1 Diabetes trial