Diamyd Medical AB has announced that its DIAGNODE-3 Phase 3 trial has reached a significant recruitment milestone, enrolling 180 patients. This achievement exceeds the recruitment target necessary for the planned early readout scheduled for March 2026. The data from this readout is intended to support a potential accelerated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).
DIAGNODE-3 is a precision medicine trial evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes (T1D). The trial is designed to assess the efficacy of Diamyd® in preserving beta cell function, as measured by C-peptide levels, and improving glycemic control, indicated by HbA1c levels. The study focuses on a genetic subgroup of T1D patients carrying the HLA DR3-DQ2 haplotype, identified as potentially more responsive to the Diamyd® treatment.
The trial builds upon previous clinical data that suggests Diamyd® has the potential to preserve beta cell function in individuals with Type 1 Diabetes, especially those within the HLA DR3-DQ2 haplotype. The primary endpoints of DIAGNODE-3 include the preservation of endogenous insulin production, measured by C-peptide levels, and the improvement of glycemic control, measured by HbA1c. Approximately 330 patients will be followed for 24 months to collect comprehensive data.
Diamyd® received Fast Track designation from the FDA in 2024 for the treatment of Stage 1, 2, and 3 Type 1 Diabetes. In July of this year, the FDA acknowledged C-peptide as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd®.
Recruitment efforts for the DIAGNODE-3 trial will continue to ensure comprehensive data collection from the full trial cohort of approximately 330 patients that will be followed for a total of 24 months.
