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, which is anticipated in March 2026. The readout is designed to support a potential accelerated Biologics License Application (BLA).
Trial Progress and Objectives
The DIAGNODE-3 trial is evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes. The trial builds upon previous clinical data suggesting Diamyd®'s potential to preserve beta cell function, particularly in individuals carrying the HLA DR3-DQ2 haplotype. The trial aims to assess the preservation of endogenous insulin production, measured by C-peptide levels, and glycemic control, measured by HbA1c.
Ulf Hannelius, CEO of Diamyd Medical, stated, “We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout. 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. With Fast Track designation, orphan drug designation and alignment with the FDA on the accelerated approval pathway, Diamyd Medical remains committed to transforming Type 1 Diabetes care through precision medicine.”
Regulatory Pathway and Trial Design
The enrollment of 180 patients ensures that at least 170 evaluable patients will be included in the early readout. Recruitment efforts will continue to ensure comprehensive data collection from the full trial cohort of approximately 330 patients, who will be followed for 24 months. Diamyd® received Fast Track designation in 2024 for the treatment of Stage 1, 2, and 3 Type 1 Diabetes. The FDA has also acknowledged C-peptide as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd®.
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® has been granted Orphan Drug Designation in the U.S. and Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes. The company is also developing Remygen®, a GABA-based investigational drug, for the treatment of metabolic diseases.
