Diamyd Medical AB has announced an in-depth analysis demonstrating robust treatment effects of Diamyd® in Type 1 Diabetes patients with the HLA DR3-DQ2 genotype across multiple clinical trials. The analysis, presented at the (IDS) Congress in Bruges, Belgium, supports the potential of Diamyd as a precision medicine approach to slow disease progression.
Consistent C-Peptide Preservation Across Trials
The meta-analysis included data from 627 patients, focusing on DR3-DQ2 positive individuals treated with high-dose Diamyd (3 or 4 injections). Key findings from individual trials include:
- D/P2/04/3 Trial: In 34 DR3-DQ2 positive patients (ages 10-18), 2 subcutaneous injections of Diamyd resulted in a 56.6% improvement in C-peptide preservation (p = 0.0106).
- D/P3/07/4 Trial: Among 109 DR3-DQ2 positive patients (ages 10-20), 4 subcutaneous injections of Diamyd led to a 37.4% improvement in C-peptide preservation (p = 0.0235).
- TrialNet 08 Trial: In 50 DR3-DQ2 positive patients (ages 3-45), 3 subcutaneous injections of Diamyd showed a 48.0% improvement in C-peptide preservation (p = 0.1458).
- DIAGNODE-2 Trial: 49 DR3-DQ2 positive patients (ages 12-24) receiving 3 intralymphatic injections of Diamyd experienced a 55.7% improvement in C-peptide preservation (p = 0.0078).
Combined Analysis Shows Significant Glycemic Control
A combined analysis of 208 DR3-DQ2 positive patients (ages 3-45) treated with 3-4 injections of Diamyd showed a significant 48.3% improvement in C-peptide preservation (p < 0.0001) and a significant reduction in HbA1c of -4.8 mmol/mol (p = 0.0044).
Impact on Hyperglycemic Excursions
Glucose monitoring data from the DIAGNODE-2 trial revealed that Diamyd significantly lowers the number, duration, and amplitude of hyperglycemic excursions. This suggests improved glycemic control beyond C-peptide preservation.
Ongoing Phase 3 Trial and Future Outlook
The results support the ongoing confirmatory Phase 3 trial DIAGNODE-3, which is evaluating the efficacy and safety of 3 intralymphatic injections of Diamyd or placebo in approximately 300 recent-onset T1D individuals (ages 12-28) who are HLA DR3-DQ2 positive. An earlier readout to support a potential accelerated Biologics License Application with C-peptide preservation as the primary endpoint, including approximately 170 patients followed for 15 months, is expected around March 2026.
Ulf Hannelius, CEO of Diamyd Medical, stated, "These analyses clarify the robustness of our previous treatment results across trials in our genetically defined responder patient group, and further characterize the effect of Diamyd® on glycemic control." He added that these insights, combined with the benign safety profile, are central for positioning Diamyd® as a best-in-class immunotherapy.
