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) to the FDA. The trial is evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes.
DIAGNODE-3 Trial Details
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 genetic subgroup of 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 of approximately 330 patients who will be followed for 24 months.
Accelerated Approval Pathway
Diamyd® has been granted Fast Track designation by the FDA 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®. This acknowledgment is a critical step toward potentially expediting the availability of Diamyd® to patients in need.
Diamyd Medical's Commitment
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." He further emphasized Diamyd Medical's commitment to transforming Type 1 Diabetes care through precision medicine, citing the Fast Track designation, orphan drug designation, and alignment with the FDA on the accelerated approval pathway.
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 the treatment of metabolic diseases. Diamyd Medical is also a major shareholder in NextCell Pharma AB and MainlyAI AB.
