Diamyd Medical has announced the successful completion of its recruitment target for the Diagnode-3 phase 3 clinical trial. The trial, designed to evaluate the efficacy of Diamyd's antigen-specific immunotherapy in individuals with recent-onset type 1 diabetes, has now enrolled 180 patients. This milestone surpasses the initial target set for the interim readout planned for March 2026, ensuring a robust dataset for analysis.
The Diagnode-3 trial is a pivotal study evaluating Diamyd's lead candidate, Diamyd, for its potential to preserve beta-cell function in individuals newly diagnosed with type 1 diabetes. The trial's design incorporates an earlier readout, anticipated around March 2026, which is intended to serve as the basis for a potential Biologics License Application (BLA) under the FDA's accelerated approval pathway. The enrollment of 180 patients ensures that at least 170 patients will be eligible for inclusion in this planned interim analysis.
While the recruitment target for the interim analysis has been met, Diamyd Medical will continue enrollment to reach the full cohort of 330 patients. These participants will be followed for a total of 24 months to gather comprehensive data on the long-term effects of the Diamyd therapy. This extended follow-up period will provide valuable insights into the durability of the treatment's effects and its potential to modify the course of type 1 diabetes.
Type 1 diabetes is an autoimmune disease characterized by the destruction of insulin-producing beta cells in the pancreas. This leads to insulin deficiency and the need for lifelong insulin therapy. Current treatments primarily focus on managing blood glucose levels, but do not address the underlying autoimmune process. Diamyd aims to halt or slow down the autoimmune destruction of beta cells, potentially preserving endogenous insulin production and improving long-term outcomes for patients with type 1 diabetes.
The Diagnode-3 trial is a randomized, double-blind, placebo-controlled study. Patients are randomized to receive either Diamyd or placebo, administered via subcutaneous injection. The primary endpoint of the trial is the change in stimulated C-peptide levels, a measure of beta-cell function, from baseline to 12 months. Secondary endpoints include measures of glycemic control, insulin requirements, and the incidence of diabetes-related complications.
The successful recruitment of patients into the Diagnode-3 trial represents a significant step forward in the development of Diamyd as a potential disease-modifying therapy for type 1 diabetes. The results of this trial, particularly the interim readout expected in March 2026, will be crucial in determining the future regulatory pathway for Diamyd and its potential to address the unmet medical need in type 1 diabetes management.
