Diamyd Medical 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 in March 2026, which is intended to support a potential accelerated Biologics License Application (BLA) with the FDA. The trial is evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes.
DIAGNODE-3 Trial Design and Objectives
The DIAGNODE-3 trial is designed to assess the efficacy of Diamyd® in preserving endogenous insulin production, as measured by C-peptide levels, and improving glycemic control, indicated by HbA1c levels. The trial focuses on a specific genetic subgroup of Type 1 Diabetes patients carrying the HLA DR3-DQ2 haplotype, building on previous clinical data that demonstrated Diamyd®'s potential to preserve beta cell function in this population.
The trial will continue to recruit patients to reach a total cohort of approximately 330 participants, who will be followed for 24 months to ensure comprehensive data collection.
Accelerated Approval Pathway
Diamyd Medical has received Fast Track designation for Diamyd® in the treatment of Stage 1, 2, and 3 Type 1 Diabetes. In July, the FDA acknowledged C-peptide as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd®. This acknowledgment paves the way for a potential accelerated approval pathway, contingent on the DIAGNODE-3 trial's success.
Executive Commentary
"We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout," said Ulf Hannelius, CEO of Diamyd Medical. "This progress reflects the engagement and the strong support from our clinical sites and the Type 1 Diabetes community in advancing innovative, precision-based therapies."
About Diamyd Medical
Diamyd Medical is focused on developing 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 designed to preserve endogenous insulin production. The company is also developing Remygen®, a GABA-based investigational drug, for metabolic diseases and has a biomanufacturing facility under development in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in Diamyd®.
