Diamyd Medical's Diamyd, an antigen-specific immunotherapy, has shown robust treatment effects in preserving beta-cell function and improving glycemic control in Type 1 Diabetes (T1D) patients, according to an in-depth analysis presented at the 2024 IDS Diabetes Congress. The analysis, which included data from multiple clinical trials, supports the potential of Diamyd as a precision medicine approach for slowing disease progression, particularly in patients positive for the HLA DR3-DQ2 genotype.
The meta-analysis included data from 627 patients, with a focus on those positive for HLA DR3-DQ2 and 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 aged 10-18, two 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 aged 10-20, four 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 aged 3-45, three subcutaneous injections of Diamyd showed a 48.0% improvement in C-peptide preservation (p = 0.1458).
- DIAGNODE-2 Trial: Among 49 DR3-DQ2 positive patients aged 12-24, three intralymphatic injections of Diamyd resulted in a 55.7% improvement in C-peptide preservation (p = 0.0078).
A combined analysis of 208 patients aged 3-45, who were positive for HLA DR3-DQ2 and treated with 3-4 injections of Diamyd, demonstrated 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).
Glycemic Control Improvements
Further insights from glucose monitoring data in the DIAGNODE-2 trial revealed a strong correlation between Diamyd treatment and improved glycemic control. Specifically, Diamyd significantly reduced the number, duration, and amplitude of hyperglycemic excursions, as well as increased time in the target glycemic range.
Ongoing Phase 3 Trial
These results support the ongoing confirmatory Phase 3 trial, DIAGNODE-3, which is designed to evaluate the efficacy and safety of three intralymphatic injections of Diamyd or placebo in approximately 300 recent-onset T1D individuals aged 12-28 who are positive for HLA DR3-DQ2. An earlier readout to support a potential accelerated Biologics License Application (BLA) with C-peptide preservation as the primary endpoint, including approximately 170 patients followed for 15 months, is expected around March 2026.
Expert Commentary
"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," said Ulf Hannelius, CEO of Diamyd Medical. "These insights, together with the benign safety profile, are central for positioning Diamyd as a best-in-class immunotherapy and in our preparations ahead of a potential accelerated approval by the U.S. FDA."
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes.
