Diamyd Medical's DIAGNODE-3 Trial Reaches Recruitment Milestone, Eyes Accelerated Approval
Key Insights
Diamyd Medical (search)'s DIAGNODE-3 trial, a Phase 3 study for Type 1 Diabetes (search), has recruited 180 patients, surpassing the target for its early readout planned in March 2026.
The early readout is designed to support a potential accelerated Biologics License Application (BLA) submission to the FDA, leveraging the Fast Track designation.
DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes (search), focusing on preserving endogenous insulin production.
Diamyd Medical (search) 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) to the FDA. The trial is evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes (search).
Advancing Precision Medicine for Type 1 Diabetes
Ulf Hannelius, CEO of Diamyd Medical (search), stated, "We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout." He emphasized the strong support from clinical sites and the Type 1 Diabetes (search) community in advancing innovative, precision-based therapies. Diamyd Medical has received Fast Track designation and orphan drug designation, and has aligned with the FDA on the accelerated approval pathway.
The enrollment of 180 patients ensures that at least 170 evaluable patients will be included in the early readout. This readout is expected around March 2026 and is designed to provide the foundation for a potential BLA submission under the FDA's accelerated approval pathway. 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.
DIAGNODE-3 Trial Details
DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy targeting a genetic subgroup of individuals with newly diagnosed Stage 3 Type 1 Diabetes (search). The trial builds on extensive clinical data demonstrating the potential of Diamyd® to preserve beta cell function in individuals with Type 1 Diabetes, particularly within the genetic subgroup carrying the HLA DR3-DQ2 haplotype. DIAGNODE-3 is designed to assess the preservation of endogenous insulin production as measured by C-peptide, as well as glycemic control measured as HbA1c. Diamyd® was granted Fast Track designation in 2024 for the treatment of Stage 1, 2 and 3 Type 1 Diabetes, and in July this year, C-peptide was acknowledged by the U.S. Food and Drug Administration (FDA) as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd®.
About Diamyd Medical
Diamyd Medical (search) develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes (search) and LADA (search) (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. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 (search) protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a component in the treatments of metabolic diseases.