An in-depth analysis of clinical trials featuring Diamyd, an antigen-specific immunotherapy, demonstrates robust treatment effects in preserving beta-cell function and improving glycemic control in Type 1 Diabetes (T1D) patients with the HLA DR3-DQ2 genotype. The findings, presented at the (IDS) Congress in Bruges, Belgium, support Diamyd's potential as a precision medicine approach to slow disease progression.
Consistent C-Peptide Preservation Across Trials
The analysis included data from multiple clinical trials, focusing on patients positive for HLA DR3-DQ2 who received either subcutaneous or intralymphatic injections of Diamyd. Key findings from individual trials include:
- D/P2/04/3 Trial: In 34 patients aged 10-18, treatment with Diamyd resulted in a 56.6% improvement in C-peptide preservation (p = 0.0106).
- D/P3/07/4 Trial: Among 109 patients aged 10-20, Diamyd led to a 37.4% improvement in C-peptide preservation (p = 0.0235).
- TrialNet 08 Trial: In 50 patients aged 3-45, Diamyd showed a 48.0% improvement in C-peptide preservation (p = 0.1458).
- DIAGNODE-2 Trial: 49 patients aged 12-24 experienced a 55.7% improvement in C-peptide preservation with Diamyd (p = 0.0078).
Combined Analysis Confirms Efficacy
A combined analysis of 208 patients aged 3-45, who were HLA DR3-DQ2 positive and treated with 3-4 injections of Diamyd, revealed a significant 48.3% improvement in C-peptide preservation (p < 0.0001). The analysis also demonstrated a significant reduction in HbA1c of -4.8 mmol/mol (p = 0.0044).
Impact on Glycemic Control
Data from the DIAGNODE-2 trial showed a strong correlation between Diamyd treatment and improved glycemic control. Specifically, Diamyd significantly lowered the number, duration, and amplitude of hyperglycemic excursions, as well as increased time in the target glycemic range.
Ongoing Phase 3 Trial
The promising results from these analyses support the ongoing Phase 3 trial, DIAGNODE-3, which is designed to confirm the efficacy and safety of Diamyd in approximately 300 recent-onset T1D individuals aged 12-28 who are positive for HLA DR3-DQ2. An earlier readout from approximately 170 patients followed for 15 months, with C-peptide preservation as the primary endpoint, is expected around March 2026, potentially supporting an accelerated Biologics License Application.
"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", says Ulf Hannelius, CEO of Diamyd Medical.
